VERTEBRAL SPACER-PR 889.847Recalls & reported problems
Synthes (U.S.A.) LP · VERTEBRAL SPACER-PR 8MMX22MM 13MM HEIGHT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10705034800363), received between May 23, 2016 and May 23, 2016 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Material Fragmentation1
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.
MalfunctionMay 23, 2016Break; Material Fragmentation; Break; Material Fragmentation
IT IS REPORTED DURING A POSTERIOR LUMBAR FUSION PROCEDURE AT L3-L4 AND L4-L5, WHILE SURGEON WAS IMPACTING THE PEEK IMPLANT (VERTEBRAL SPACER-PR) AT L3-L4, THE DEVICE SHATTERED INTO APPROXIMATELY SIX (6) PIECES. ALL THE PIECES WERE EASILY RETRIEVED. ANOTHER PEEK IMPLANT WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO FURTHER HARM TO PATIENT. THE PROCEDURE WAS DELAYED APPROXIMATELY FIVE (5) MINUTES DUE TO THIS EVENT. THE PATIENT REPORTED TO BE DOING WELL POST-OPERATIVELY. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5673549 ↗
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- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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