NA 460.035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587055091), received between Apr 15, 2019 and Oct 10, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE LARGE TITANIUM STERNAL LOCKING PLATE AND TITANIUM STERNAL LOCKING STAR PLATE BROKE INTO TWO PIECES DURING THE SURGEONS ATTEMPT TO BEND THE PLATES TO CONTOUR TO BONE. HE ATTEMPTED TO BEND ONE, THAT BROKE, THEN HE ATTEMPTED TO BEND THE SECOND. BROKEN DEVICES WERE EASILY REMOVED AS THEY WERE NOT IMPLANTED INTO THE PATIENT AT THAT TIME, SURGEON WAS BENDING THEM OFF THE SURGICAL SITE BY THE MAYO STAND. ANOTHER PLATE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS REPORTED WITH NO COMPLICATIONS. CONCOMITANT DEVICE REPORTED: UNKNOWN BENDING INSTRUMENTS: PLATE BENDER: TRAUMA (PART# /LOT# /QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING STAR PLATE 6 HOLES. THIS IS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176734 ↗
• 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 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 COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) LARGE TI STERNAL LOCKING H-PLATE/8 HOLES. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection; Wound Dehiscence

  MAUDE report 8553118 ↗
• 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 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 COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING STAR PLATE 6 HOLES. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection; Wound Dehiscence

  MAUDE report 8553107 ↗
• 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 8513965 ↗