NA 220442Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705007264), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 injury.

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.

• InjuryApr 20, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT AFTER A TIBIAL TUBERCLE OSTEOTOMY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE THREADS ON THE SCREW DEVICE BROKE INSIDE THE PATIENT´S BODY AND CAUSED THE TREATMENT TO FAIL. IT WAS REPORTED THAT THE BROKEN SCREW WAS DISCOVERED THROUGH X-RAY. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2020. ALTHOUGH THERE WAS NO SURGERY SCHEDULED FOR IT TO BE REMOVED TO DATE, THERE WAS AN ADDITIONAL PROCEDURE PLANNED TO REMOVE THE BROKEN SCREW. THE STATUS OF THE PATIENT POST=SURGERY WAS UNKNOWN BUT CURRENTLY WAITING FOR THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11692464 ↗