NA 04.501.112.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10887587017365), received between Oct 8, 2018 and Apr 25, 2019 — classified as 17 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 17 most recent of 17 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 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/12MM. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 8550371 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 9 OF 10 FOR (B)(4).

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

  MAUDE report 8550353 ↗
• 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/12MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 8550351 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 8 OF 10 FOR (B)(4).

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

  MAUDE report 8550350 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 6 OF 10 FOR (B)(4).

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

  MAUDE report 8550347 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 7 OF 10 FOR (B)(4).

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

  MAUDE report 8550344 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 5 OF 10 FOR (B)(4).

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

  MAUDE report 8550341 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 4 OF 10 FOR (B)(4).

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

  MAUDE report 8550340 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISCENCE 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 3 OF 10 FOR (B)(4).

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

  MAUDE report 8550338 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 10 OF 10 FOR (B)(4).

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

  MAUDE report 8550335 ↗
• 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, SURGEON IMPLANTED FIVE (5) STERNAL PLATES AND THIRTY-TWO (32) STERNAL SCREWS INTO PATIENT FOR NON-UNION STERNUM FOLLOWING A STERNOTOMY. 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. IT WAS REPORTED ON (B)(6) 2019, THAT PATIENT'S PLATES AND SCREWS HAD DEHISENCED 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. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-SEVEN (37) DEVICES. THIS (B)(4) CAPTURES TEN (10) DEVICES WHILE REMAINING DEVICES ARE CAPTURE UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) STERNAL LOCKING SCREW. THIS IS REPORT 2 OF 10 FOR (B)(4).

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

  MAUDE report 8550332 ↗
• 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/12MM. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 8550315 ↗
• 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/12MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 8550302 ↗
• 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/12MM. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

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

  MAUDE report 8550266 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  UPDATE: APRIL 10, 2019 . THE MALE PATIENT WAS REVISED DUE TO INFECTION. ALL HARDWARE WAS REMOVED INTACT. THE INTERVENTION AFTER THE REMOVAL OF THE IMPLANTS IS UNKNOWN. ALONG WITH THE REPORTED PLATES, THE PATIENT WAS IMPLANTED WITH THE FOLLOWING DEVICES: 04.501.112.01 QTY. (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM , 04.501.114.01 QTY. (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM , 04.501.116.01 QTY. (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM , 04.501.118.01 QTY. (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM.

  Patient problems: Unspecified Infection

  MAUDE report 8514011 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  UPDATE: APRIL 10, 2019 . THE MALE PATIENT WAS REVISED DUE TO INFECTION. ALL HARDWARE WAS REMOVED INTACT. THE INTERVENTION AFTER THE REMOVAL OF THE IMPLANTS IS UNKNOWN. ALONG WITH THE REPORTED PLATES, THE PATIENT WAS IMPLANTED WITH THE FOLLOWING DEVICES: 04.501.112.01 QTY. (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/12MM , 04.501.114.01 QTY. (18) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/14MM , 04.501.116.01 QTY. (5) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/16MM , 04.501.118.01 QTY. (2) TITANIUM STERNAL LOCKING SCREW SELF-DRILLING/18MM.

  Patient problems: Unspecified Infection

  MAUDE report 8513997 ↗
• InjuryOct 8, 2018Unintended Movement; Unintended Movement

  CONCOMITANT DEVICE: F/STERNAL LOCKING PLATE (PART: 413.582, LOT: UNKNOWN, QUANTITY: 1).

  Patient problems: Failure of Implant

  MAUDE report 7942932 ↗