Variable Angle Non-Locking Screw FBS 508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118101776), received between Nov 29, 2017 and Nov 29, 2017 — classified as 1 malfunction.

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

• MalfunctionNov 29, 2017Material Fragmentation; Material Fragmentation

  DURING SURGERY, AFTER A PILOT HOLE HAD BEEN DRILLED, FBS 508 VARIABLE ANGLE NON-LOCKING SCREW, 1.5MM X 8MM WAS INSERTED AND BROKE DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7066858 ↗

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