T-PAL 08.812.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034759548), received between Mar 5, 2018 and Jan 9, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A SURGERY ON (B)(6), 2018. PATIENT UNDERWENT EXTENDED RE-FUSION SURGERY ON DECEMBER 18, 2023, DUE TO ADJACENT INTERVERTEBRAL DISORDERS. TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WAS PERFORMED ON L2/3 AND EXTENDED. POSTERIOR LUMBAR INTERBODY FUSION (PLIF) WAS PERFORMED ON L1/2. IT IS CONFIRMED L4/5 ACHIEVED OSTEOSYNTHESIS. THIS REPORT IS FOR A T-PAL SPACER 10MM X 28MM 9MM HEIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18475722 ↗
• InjuryMar 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED FOR A POSTERIOR SPINAL (LUMBAR) FUSION REVISION SURGERY ON (B)(6) 2018 DUE TO MIGRATION OF THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER INTO THE FOREMAN WITH POSSIBLE HARDWARE DUE TO LEG PAIN BELIEVED TO BE CAUSED BY THE DEVICE MIGRATION SECONDARY TO A POST-OPERATIVE FALL. THE ORIGINAL SURGERY WAS PERFORMED ON AN UNKNOWN DATE AND THE PATIENT WAS IMPLANTED WITH THE T-PAL SPACER. POST-OPERATIVELY, ON AN UNKNOWN DATE THE PATIENT HAD A FALL DURING THE SUMMER. THE DEVICE MALFUNCTION WAS DETECTED THROUGH POST-OP X-RAYS. THE PATIENT DID NOT HAVE ANY NEW INJURIES RELATED TO THE POST-OPERATIVE FALL. THE PATIENT IS ALSO EXPECTED TO UNDERGO A REVISION LAMINECTOMY TO RELIEVE THE PAIN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7313101 ↗

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