NA 218.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982155948), received between Feb 26, 2018 and Feb 26, 2018 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6), 2018, WHILE THE SURGEON WAS IMPLANTING A DYNAMIC COMPRESSION PLATE SYSTEM, A 6.5MM CANCELLOUS BONE SCREW WAS BROKEN WHILE BEING IMPLANTED IN A PATIENT. IT WAS FURTHER EXPLAINED THAT THE THREADED SHAFT REMAINED IN THE PATIENT WHILE THE HEAD AND A PORTION OF THE THREADED SHAFT SHEARED OFF. THE BROKEN HEAD WAS REMOVED AND THE SURGERY WAS COMPLETED WITHOUT ANY HARM OR INJURY TO THE PATIENT. THE SURGEON DECIDED TO PLACE A SCREW PARALLEL TO THE BROKEN SCREW AND THE PLACEMENT OF THIS ADDITIONAL SCREW DID NOT INTERFERE WITH THE SURGICAL TECHNIQUE/PLAN. THERE ARE NO PLANS TO PROVIDE ANY ADDITIONAL MEDICAL INTERVENTION; THE PATIENT WILL NOT BE REVISED. CONCOMITANT MEDICAL PRODUCTS: DYNAMIC COMPRESSION PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297454 ↗