NA 498.800.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982236920), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2017Unraveled Material; Unintended Movement; Unraveled Material; Unintended Movement

  IT WAS REPORTED THAT A 1MM TITANIUM CABLE WAS IMPLANTED ON (B)(6) 2017 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PATELLA. THE CABLE WAS THREADED THROUGH 4MM HEADLESS CANNULATED SCREWS (ZIMMER DEVICES). THE CABLE BECAME UNRAVELED AND NO LONGER HELD AROUND THE PATELLA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WHERE THE PATIENT WAS REVISED TO ANOTHER 1MM TITANIUM CABLE. PATIENT WAS REPORTED AS STABLE FOLLOWING THE SURGERY AND THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 1.0MM TI CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7086964 ↗