NA 04.168.510SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982274649), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE ON AN UNKNOWN DATE, THE ANTIROTATION SCREW FOR FEMORAL NECK SYSTEM DID NOT LOCK INTO THE FEMORAL NECK BOLT. IN ADDITION, THE MEASURING FOR THE FEMORAL NECK BOLT MEASURED LONG. THE SURGEON WENT BACK AND RE-TIGHTENED THE ANTIROTATION SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: FNS BOLT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 110MM LENGTH - STER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7801922 ↗