T-PAL 08.812.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034759555), received between Mar 17, 2022 and Mar 24, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100089); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO A DISLODGED TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) SPACER. PATIENT EXPERIENCED MULTIPLE FALLS FOLLOWING INITIAL SURGERY ON (B)(6) 2022. THIS REPORT IS FOR A T-PAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13893902 ↗
• MalfunctionMar 17, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SILVER BUTTON BECAME STUCK, AND THE SURGEON WAS UNABLE TO RELEASE THE CAGE. ANOTHER CAGE WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) T-PAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801681 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100089. One submission often covers many models, so check the product and lot details in each record.

• Z-0161-2012 · Sep 23, 2011 · Terminated
  Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is ind