NA 04.501.114.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10887587017396), received between May 3, 2018 and Apr 25, 2019 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 7 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550847 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 6 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550769 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT DUE TO NON-UNION OF STERNUM FOLLOWING A STERNOTOMY. DATE OF IMPLANTATION WAS ON (B)(6) 2019. AT TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE THROUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS EVENT INVOLVES TOTAL THIRTY-SEVEN (37) DEVICES. THIS COMPLAINT (B)(4) ADDRESSES TOTAL 10 OF THESE DEVICES. REMAINING 27 DEVICES ARE ADDRESSED IN COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/14MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550695 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 5 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550689 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT DUE TO NON-UNION OF STERNUM FOLLOWING A STERNOTOMY. DATE OF IMPLANTATION WAS ON (B)(6) 2019. AT TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE THROUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS EVENT INVOLVES TOTAL THIRTY-SEVEN (37) DEVICES. THIS COMPLAINT (B)(4) ADDRESSES TOTAL 10 OF THESE DEVICES. REMAINING 27 DEVICES ARE ADDRESSED IN COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/14MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550681 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 4 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550658 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT DUE TO NON-UNION OF STERNUM FOLLOWING A STERNOTOMY. DATE OF IMPLANTATION WAS ON (B)(6) 2019. AT TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE THROUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS EVENT INVOLVES TOTAL THIRTY-SEVEN (37) DEVICES. THIS COMPLAINT (B)(4) ADDRESSES TOTAL 10 OF THESE DEVICES. REMAINING 27 DEVICES ARE ADDRESSED IN COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/14MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550657 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT DUE TO NON-UNION OF STERNUM FOLLOWING A STERNOTOMY. DATE OF IMPLANTATION WAS ON (B)(6) 2019. AT TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED THROUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS EVENT INVOLVES TOTAL THIRTY-SEVEN (37) DEVICES. THIS COMPLAINT (B)(4) ADDRESSES TOTAL 10 OF THESE DEVICES. REMAINING 27 DEVICES ARE ADDRESSED IN COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/14MM. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550454 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT DUE TO NON-UNION OF STERNUM FOLLOWING A STERNOTOMY. DATE OF IMPLANTATION WAS ON (B)(6) 2019. AT TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED THROUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS EVENT INVOLVES TOTAL THIRTY-SEVEN (37) DEVICES. THIS COMPLAINT (B)(4) ADDRESSES TOTAL 10 OF THESE DEVICES. REMAINING 27 DEVICES ARE ADDRESSED IN COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/14MM. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550402 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 3 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550316 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 2 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550289 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOLLOWING A STERNOTOMY. AT THE TIME OF IMPLANTATION, PHYSICIAN WAS HAPPY WITH HOW SCREWS HAD PURCHASED AND CHECKED MULTIPLE TIMES THE REDUCTION AND TACTILE STRENGTH OF THE FIXATION ALONG THE STERNUM. THE SALES CONSULTANT WAS INFORMED VIA PHONE CALL ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCED THOUGH THE BONE AND HAD BECOME INFECTED. PHYSICIAN DID NOT THINK THAT THIS INFECTION WAS CAUSED BY THE IMPLANTS, BUT MORE BY A PATIENT'S COMPLIANCE AND PAST HISTORY. ALL THIRTY-TWO (32) SCREWS AND FIVE (5) PLATES WERE REMOVED FROM THE PATIENT ON (B)(6) 2019, WITH NO COMPLICATIONS AND NO PRODUCT ISSUE OR MALFUNCTION WAS REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM TITANIUM (TI) STERNAL LOCKING SCREW SELF-DRILLING 14MM. THIS IS REPORT 1 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8550241 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515366 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515360 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515359 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515356 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515346 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515340 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515339 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515338 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES TEN (10) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8515335 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES (9) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8514223 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES (9) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 8 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8514202 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES (9) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 7 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8514176 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL FROM A CHEST WALL DUE TO INFECTION ON (B)(6) 2019. THE SURGEON REMOVED ONE (1) TITANIUM STERNAL LOCKING STAR PLATE, ONE (1) TITANIUM STERNAL LOCKING X PLATE, AND UNKNOWN SCREWS. THE PARTS THAT WERE REMOVED WERE EXTERNAL RECONSTRUCTION PLATES AND SCREW. ALL HARDWARE WAS REMOVED INTACT. ALONG WITH THE REPORTED PLATES THE PATIENT WAS ALSO IMPLANTED WITH THE TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM, EIGHTEEN (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM, FIVE (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM, AND TWO (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES TOTAL OF TWENTY-NINE (29) IMPACTED PRODUCTS. DUE TO SYSTEM LIMITATION OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT CAPTURES (9) DEVICES OUT OF TWENTY-NINE (29), WHILE (B)(4) CAPTURES OTHER TEN (10) DEVICES AND (B)(4) CAPTURES OTHER TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.0MM TI STERNAL LOCKING SCREW-SELF DRILLING /14 MM. THIS IS REPORT 6 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8514156 ↗