TSPACE® PEEK SJ911PRecalls & reported problems
Aesculap AG · TSPACE PEEK IMPLANT 5° 26X11.5X11MM · Class 2 · Implant
Data updated Oct 16, 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 04046963805371), received between Sep 18, 2020 and Sep 18, 2020 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2020Break; Break
IT WAS REPORTED TO AESCULAP AG THAT A TSPACE PEEK IMPLANT (5° ANGLE, 26 MM LENGTH, 11.5 MM WIDTH, 11 MM HEIGHT) WAS USED DURING A SURGICAL PROCEDURE. ACCORDING TO THE COMPLAINANT, THE IMPLANT FRACTURED WHILE ATTEMPTING TO PLACE IN THE DISC AREA. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THE PROCEDURE WAS DELAYED APPROXIMATELY TWENTY (20) MINUTES. THE PATIENT WAS NOTED AS HAVING "MILD" INJURIES. THE TREATMENT WAS INDICATED AS HAVING BEEN FINE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10555966 ↗
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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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