NA 42.231.260TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982307026), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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.

• InjuryApr 27, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON TOOK X-RAYS AND IT SHOWS 5.0 MM VARIABLE ANGLE LOCKING SCREWS, OPTILINK SELF-TAPPING, T25 STARDRIVE WAS LOOSENED OUT OF AN UNKNOWN PLATE. THE 5.0 MM VARIABLE ANGLE LOCKING SCREWS, OPTILINK SELF-TAPPING, T25 STARDRIVE NEEDED TO REMOVE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATES: CONDYLAR (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES (1) DEVICE 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/ST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14219960 ↗