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OASYS 48555322Recalls & reported problems

Stryker Corporation · MEDIAL BIAS POLYAXIAL SCREW · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540469540), received between Jun 29, 2016 and Jun 29, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1
  • Disassembly1
  • Mechanical Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 29, 2016Detachment Of Device Component; Disassembly; Mechanical Problem; Disassembly; Mechanical Problem

    IT WAS REPORTED THAT; WHEN REMOVING A SCREW FROM THE T1 VERTEBRAE THE TULIP HEAD OF THE SCREW FELL OFF. THE REST OF THE SCREW THEN CAME OUT WITHOUT ANY HARM TO THE PATIENT. THE SCREW WILL BE SENT BACK TO YOU FOR FURTHER INSPECTION. THERE WAS NO HARM DONE TO THE PATIENT. PATIENT WAS FUSED AT THOSE LEVELS THEY WERE TAKING THE SCREWS OUT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 5759563 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.