Locking Stabilization Screw 37251-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120047305195), received between Jul 10, 2017 and Jul 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K142418); 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.

• MalfunctionJul 10, 2017Device Handling Problem; Device Handling Problem

  THE SURGEON WAS ENGAGING THE SCREW INTO THE PLATE AND ENTIRE HEAD POPPED OFF THE SCREW. THE HEAD OF THE SCREW REMAINED ON THE SCREWDRIVER. THE REST OF THE SCREW WAS LEFT IN THE PATIENT, BUT NO ADVERSE EFFECTS ARE APPARENT.

  Patient problems: No Information

  MAUDE report 6696336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142418. One submission often covers many models, so check the product and lot details in each record.

• Z-1607-2026 · Jan 23, 2026 · Open, Classified
  HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11,