NA 460.046Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587055251), received between Dec 26, 2018 and Jan 30, 2020 — classified as 3 injuries, 1 malfunction.

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 18, 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.

• MalfunctionJan 30, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, ONE (1) STEPPED DRILL BIT CANNULATED DID NOT FUNCTION; SIX (6) DEPTH GAUGE FOR LOCKING SCREWS, TWO (2) LOCKING BOLT MEASURING DEVICE, AND ONE (1) TITANIUM STERNAL LOCKING STRAIGHT PLATE WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN. THIS IS REPORT 07 OF 10 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647726 ↗
• InjuryJan 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE OF TWO (2) TITANIUM STERNAL LOCKING STRAIGHT PLATES AND TWENTY-THREE (23) UNKNOWN SCREWS DUE TO NONUNION AND BROKEN PLATES. IT WAS NOTED THAT THE PLATES AND SCREWS CAME OUT OF THE PATIENT. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE (ORIF) WITH IMPLANTATION OF THE PLATES AND UNKNOWN SCREWS ON (B)(6) 2015, TO REPAIR AN EXTERNAL FRACTURE. IT IS UNKNOWN IF THERE WERE FRAGMENTS FROM THE BROKEN DEVICES. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT REPORTED DEVICES: UNKNOWN SCREWS (PART # UNKNOWN, LOT NUMBER#, QUANTITY: 23). THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8249396 ↗
• InjuryJan 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE OF TWO (2) TITANIUM STERNAL LOCKING STRAIGHT PLATES AND TWENTY-THREE (23) UNKNOWN SCREWS DUE TO NONUNION AND BROKEN PLATES. IT WAS NOTED THAT THE PLATES AND SCREWS CAME OUT OF THE PATIENT. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE (ORIF) WITH IMPLANTATION OF THE PLATES AND UNKNOWN SCREWS ON (B)(6) 2015, TO REPAIR AN EXTERNAL FRACTURE. IT IS UNKNOWN IF THERE WERE FRAGMENTS FROM THE BROKEN DEVICES. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT REPORTED DEVICES: UNKNOWN SCREWS (PART # UNKNOWN, LOT NUMBER#, QUANTITY: 23). THIS REPORT IS FOR ONE (1) TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8249394 ↗
• InjuryDec 26, 2018Break; Break

  CONCOMITANT DEVICES: TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN (PRODUCT CODE: 460.046, LOT NUMBER: 7260429, QUANTITY: 1). UNK - SCREWS: TRAUMA (PRODUCT CODE: UNKNOWN, LOT NUMBER: UKNOWN, QUANTITY: 13).

  Patient problems: Inflammation; Pain

  MAUDE report 8197930 ↗