TSPACE® PEEK SJ908PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963835880), received between Sep 18, 2020 and Sep 18, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS AN TSPACE PEEK IMPLANT 5° 26X11.5X10MM. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT DURING PROCEDURE WHILE PUTTING THE DISC IN THE DISC AREA, THE PRODUCT WAS BROKEN. ADDITIONAL INFORMATION RECEIVED, THAT THE DISC WAS REPLACED BY THE NEW ONE AND THE TREATMENT WAS FINE. PATIENT HAD MILD INJURIES AND THERE WAS A 20 MINS DELAY DURING THE SURGERY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10556721 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH TSPACE PEEK IMPLANT 5° 26X11.5X8MM ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT DURING PROCEDURE WHILE PUTTING THE DISC IN THE DISC AREA, THE PRODUCT WAS BROKEN. ADDITIONAL INFORMATION RECEIVED THAT THE DISC WAS REPLACED BY THE NEW ONE, AND THE TREATMENT WAS FINE. PATIENT HAD MILD INJURIES AND THERE WAS A 20 MINS DELAY DURING THE SURGERY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10556497 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT A TSPACE PEEK IMPLANT (5° ANGLE, 26 MM LENGTH, 11.5 MM WIDTH, 8 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 10555956 ↗