NA 460.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587055121), received between Sep 14, 2018 and Feb 25, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE ON (B)(6) 2020 TO REMOVE THE STAR PLATE DUE TO NON-UNION. THE PLATE WAS BROKEN ONCE SURGEON GOT IN. THE PLATE WAS REMOVED SUCCESSFULLY, AREA WAS WASHED OUT, NO ADDITIONAL RIGID FIXATION, SOFT TISSUE CLOSURE. THERE WAS A DELAYED HEALING BUT NONE HAD SOME GAP DURING INITIAL PLATING, NOT COMPLETELY REDUCED WHEN PLATE WAS FIRST PUT IN. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. PATIENT WAS IMPLANTED WITH PLATE AND SCREWS APPROXIMATELY 2 MONTHS AGO.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9752024 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TITANIUM STERNAL LOCKING STAR PLATE WAS RECEIVED STILL IN THE PACKAGING LOOKING BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TITANIUM (TI) STERNAL LOCKING STAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8739801 ↗
• 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- 12 HOLES. THIS REPORT IS 1 OF 10 FOR (B)(4).

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

  MAUDE report 8553106 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2018, A PIECE OF A TITANIUM STERNAL LOCKING STAR PLATE BROKE OFF WHILE BEING BENT BY TWO (2) UNIVERSAL BENDING PLIERS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. CONCOMITANT DEVICES: UNIVERSAL BENDING PLIERS (PART 391.963.96, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) STERNAL LOCKING STAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7932322 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT A 12 HOLES-TITANIUM STERNAL LOCKING STAR PLATE BROKE DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018. THE PLATE BROKE WHEN THE SURGEON USED A PLATE BENDER. ANOTHER 12 HOLES-TITANIUM STERNAL LOCKING STAR PLATE WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY CONCOMITANT DEVICE REPORTED : UNKNOWN PLATE BENDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1). (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876420 ↗