Variable Angle Non-Locking Screw FBS 355Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118100465), received between Dec 11, 2017 and Dec 11, 2017 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K131657); 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 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.

• MalfunctionDec 11, 2017Misconnection; Misconnection

  FBS 355 SCREW HEAD BROKE WHILE DR. (B)(6) WAS TRYING TO REDUCE THE PLATE ONTO THE BONE USING THE SCREW. THE SCREW HEAD WAS EXPLANTED AND THE SCREW BODY WAS LEFT WITHIN THE PATIENT. THE PATIENT WAS NOT HARMED AND THE SCREW WOULD NOT BE EXPLANTED IN THE FUTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7105534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131657. One submission often covers many models, so check the product and lot details in each record.

• 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