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AVS PL 48345094Recalls & reported problems

Stryker Corporation · VERTEBRAL SPACER · 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 07613154129379), received between Jun 8, 2016 and Jun 8, 2016 — classified as 1 malfunction.

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

  • Fracture1
  • Material Fragmentation1

Patient problems

  • 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 8, 2016Fracture; Material Fragmentation; Fracture

    IT WAS REPORTED THAT WHILE IMPACTING A 9X25X4 DEGREE 8 STRAIGHT CAGE INTO L5-S1 DISC SPACE THE CAGE BROKE INTO MULTIPLE PIECES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5707565 ↗

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