N/A 323.1013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036272319), received between Nov 4, 2020 and Nov 4, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 WAS SUGGESTED THAT 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 10784360 ↗