T-PAL 08.812.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034759524), received between Oct 31, 2017 and Jan 9, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 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 (B)(6) 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 7MM HEIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER PC-001504472 AND PC-001505128.

  Patient problems: Osteolysis

  MAUDE report 18475628 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR SPACER SYSTEM (T-PAL) SPACER BROKE DURING INSERTION. THERE WAS A SURGICAL DELAY FOR TWO (2) MINUTES. PATIENT OUTCOME WAS UNKNOWN. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN T-PAL INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7858019 ↗
• InjuryOct 31, 2017Break; Break

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2017 WHEN A SURGEON TOOK A MALLET AND TAPPED THE TOP OF THE INSERTION DEVICE TO ADVANCE THE IMPLANT INTO THE DESIRED LOCATION HE REALIZED THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER 10MM X 28MM 7MM HEIGHT HAD BROKEN INTO TWO PIECES. ONE SMALL PIECE REMAINED ATTACHED TO THE INSERTER AND THE OTHER BROKEN PIECE WAS REMOVED FROM THE DISC SPACE. THE SURGEON THEN INSERTED A SYNTHES OPAL SPACER INTO THE DISC SPACE INSTEAD OF TRYING ANOTHER T-PAL. THERE WAS A SURGICAL DELAY OF 25MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: T-PAL SPACER APPLICATOR HANDLE (PART 03.812.001, LOT 3409318, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-PAL SPACER 10MM X 28MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6992272 ↗

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