N/A 323.1033Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036272395), received between Nov 4, 2020 and Mar 31, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11598979 ↗
• InjuryNov 4, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE RIB PLATE POST WAS NOT LONG ENOUGH TO GO THROUGH THE PATIENT'S RIB RESULTING IN A THREE (3) HOUR SURGICAL DELAY. THE BRIDGE POST WOULD NOT COME THROUGH THE PILOT HOLE ENOUGH FOR THE LOCKING CAP TO ENGAGE WITH THE THREADS. THE SURGEON DRILLED THE PILOT HOLE PERPENDICULARLY AND WAS PULLING UP ON THE CABLE WHILE ANOTHER SURGEON WAS APPLYING PRESSURE TO THE BRIDGE FROM INSIDE THE CHEST. IT IS POSSIBLE TISSUE OR A CALLOUS PREVENTED THE BONE FROM APPROXIMATING. THE DISPLACED FRACTURED WAS PLATED WITH AN ALTERNATIVE PRODUCT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10784363 ↗