T-PAL 08.812.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034759562), received between Nov 30, 2021 and Jan 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: WOUND INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE T-PAL PEEK PRODUCT (T-PAL SPACER 10MM X 28MM 11MM HEIGHT (B)(4).

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 18465806 ↗
• InjuryNov 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN L4/5 (TLIF) TRANSFORAMINAL LUMBAR INTERBODY FUSION DONE 8-10 WEEKS AGO USING A TPAL SPACER. DURING A POST-OPERATIVE VISIT TO THE CLINIC LOOKING AT X-RAYS. THE SURGEON NOTICED THE SPACER HAD MIGRATED POSTERIORLY AND WOULD NEED TO BE REMOVED. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) T-PAL SPACER 10MM X 28MM 11MM HEIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12900386 ↗

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