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OASYS 48558320Recalls & reported problems

Stryker Corporation · NON-BIASED 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 04546540596352), received between Aug 6, 2019 and Aug 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Detachment of Device or Device Component1
  • Difficult to Remove1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 6, 2019Break; Difficult to Remove; Detachment of Device or Device Component; Detachment of Device or Device Component

    PHYSICIAN REPORTED THAT THE TULIP HEAD OF AN OASYS SCREW BECAME DETACHED DURING IMPLANTATION. THE SCREW WAS, "TAKEN OUT AFTER GREAT DIFFICULTY AND REPLACED" RESULTING IN A ONE HOUR DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8864152 ↗

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.