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OASYS 48552442Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540371867), received between Mar 1, 2019 and Nov 26, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

  • Fracture2
  • Break1

Patient problems

  • Injury2
  • No Code Available1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 26, 2019Fracture

    PHYSICIAN REPORTED THAT AN OASYS POLYAXIAL SCREW MEANT TO CORRECT AN ODONTOID FRACTURE AND ATLANTOAXIAL SUBLUXATION AT C1-C2, FRACTURED IN (B)(6) OF 2013. THE PATIENT WAS NOT REVISED FOR THIS ISSUE.

    Patient problems: Injury

    MAUDE report 9379676 ↗
  • InjuryMar 1, 2019Break; Fracture; Fracture

    IT WAS REPORTED THAT THE SCREW ON ONE SIDE WAS BROKEN POST-OPERATIVELY. ADDITIONALLY THE PATIENT ALSO PRESENTED A SLIP ON C4/C5 POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 FOR REPLACEMENT OF SCREW AND EXTENSION OF TREATMENT SECTION.

    Patient problems: Injury; No Code Available

    MAUDE report 8383582 ↗

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.