Variable Angle Locking Screw FLP 322Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118104579), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K123562); they may or may not involve this specific model.

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.

• InjuryMar 30, 2021Fracture; Fracture

  A 3.0MM X 22MM LOCKING SCREW (FLP 322) SCREW BROKE AFTER NEARLY 9 MONTHS OF IMPLANTATION. THIS EVENT IS ASSOCIATED WITH THE SAME PATIENT AND SURGICAL PROCEDURE AS DESCRIBED IN MDR 3009996260-2021-00003 AND 3009996260-2021-00005.

  Patient problems: Implant Pain

  MAUDE report 11589135 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123562. One submission often covers many models, so check the product and lot details in each record.

• Z-0034-2022 · Sep 3, 2021 · Terminated
  Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
• Z-1314-2015 · Feb 16, 2015 · Terminated
  Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm