SynFix-LR 03.802.039Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034722252), received between Aug 21, 2018 and Aug 21, 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.

• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE THREADED TIP OF THE IMPLANT HOLDER FOR A SYNFIX LR IMPLANT BROKE OFF WHEN LOADING THE IMPLANT. THE BROKEN TIP WAS REMOVED FROM THE IMPLANT AND THE SYNFIX LR QUICK INSERTER/DISTRACTOR (SQUID) WAS USED FOR INSERTION. FRAGMENTS WERE GENERATED FROM BROKEN DEVICE BUT WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO-MINUTE DELAY. PATIENT OUTCOME IS GOOD. CONCOMITANT DEVICES: SYNFIX LR IMPLANT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN IMPLANT HOLDER FOR SYNFIX (TM)-LR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7801869 ↗