AVS PL 48340114Recalls & reported problems
Stryker Corporation · VERTEBRAL SPACER · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154129263), received between Sep 1, 2016 and Sep 1, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
- Insufficient Device Problem Information1
Patient problems
- Pain1
- Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2016Biocompatibility; Insufficient Device Problem Information; Biocompatibility
IT WAS REPORTED THAT; PATIENT RECEIVED A POSTERIOR LUMBAR DECOMPRESSION INFUSION AT L4-L5 IN (B)(6) 2014. SHE RECENTLY STARTED TO EXPERIENCE A LOT OF ACHING AND PAIN AND HER SURGEON SUGGESTS THIS MAY BE AN ALLERGIC REACTION TO THE IMPLANT.
Patient problems: Pain; Reaction
MAUDE report 5920655 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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