T-PAL 03.812.310Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034727851), received between Dec 29, 2016 and Jun 23, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A TPAL 10MM SMALL TRAIL DAMAGED IN THEATRE. THE TRIAL WAS INSERTED INTO THE SHAFT BUT WOULD NOT ENGAGE THE APPLICATOR KNOB, IT LOOKED LIKE THE LOCKING MECHANISM ON THE TRIAL HAS BROKEN OFF INSIDE THE APPLICATOR KNOB, MEANING THE APPLICATOR KNOB ALSO CAN NOT BE USED. THERE WAS NO PATIENT HARM, NO DELAY TO SURGERY, AND NO ADVERSE EVENT AS THERE WAS A SECOND KIT AVAILABLE IN THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309854 ↗
• MalfunctionJun 4, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, PRE-OPERATIVELY IT WAS NOTICED THAT THE BALL CLIP (DISTAL END) ON THE TWO INSTRUMENTS ARE MISSING, AND ONE OF WHICH WAS JAMMED IN THE HANDLE. THE DEVICE HAS NOT BEEN IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459898 ↗
• MalfunctionAug 13, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DEVICE BROKE INSIDE ITS INSERTION HANDLE BECOMING UNUSABLE DURING AN PPEN DEGEN SURGERY OF THE L5 S1. THE INSTRUMENTS WERE ASSEMBLED WITHOUT DIFFICULTIES. AFTER THE TEST OF THE CAGE WAS CARRIED OUT AND AFTER IT WAS REMOVED FROM THE PATIENT, WHEN THE INSTRUMENT WAS DISASSEMBLED, IT WAS VERIFIED THAT THE INTERNAL SHAFT OF THE TEST CAME OUT WITHOUT THE BACK. THE SAME WAS INSIDE THE METALLIC HANDLE THAT WAS LATER REMOVED. THE EPISODE WAS INTRAOPERATIVELY BUT WITHOUT PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319363 ↗
• MalfunctionDec 15, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING SURGERY THE TRIAL IMPLANT SIZE 10 BROKE OFF IN THE INSERTER DURING THE REMOVAL OF THE TRIAL IMPLANT. NO PARTS REMAINED IN THE PATIENT AND NO SURGICAL DELAY WAS REPORTED. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. CONCOMITANT DEVICE REPORTED: APPLICATOR OUT SHAFT (PART# 03.812.001, LOT# UNKNOWN, QUANTITY 1). APPLICATOR KNOB (PART# 03.812.004, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11006467 ↗
• MalfunctionAug 6, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING SURGERY ON AN EVALUATION ORDER # 57079608, THE END OF A T-PAL TRIAL SPACER 10 MM BROKE OFF DURING THE HAMMER IMPACTION. THE SURGEON WAS DOING TWO LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION. DURING THE TRAILING STAGE OF LEVEL L4-L5, THE SURGEON WAS TRYING TO GET THE 10 MM TPAL TRIAL INTO THE SPACE. BUT THE TRIAL BECAME LOOSE, AND THE TRAIL COULD NOT TIGHTEN BACK AGAIN. THERE WAS AROUND 2 MINUTES OF SURGICAL DELAY TO USE A 9 MM TRIAL AND IMPLANT A 10 MM TPAL SPACER. ALL BROKEN PIECES WERE RETRIEVED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPACTION INSTRUMENTS: HAMMER/MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8866648 ↗
• MalfunctionJun 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A TRANSFORAMINAL POSTERIO ATRAUMATIC LUMBAR (T-PAL) SMALL TRIAL IMPLANT CAGE 11MM AND 10MM IN HEIGHT RESPECTIVELY BROKE OFF ON ITS ROUND TIP DURING A ONE LEVEL FIXATION PROCEDURE. THE BROKEN PART GOT STUCK IN AN UNKNOWN T-PAL INSERTER, HOWEVER, IT WAS TAKEN OFF WITH THE HELP OF THE SALES CONSULTANT TO LOOSEN THE PART THROUGH DEMONSTRATION. THE SURGERY WAS COMPLETED BY USING A NEW SMALLER TRIAL IMPLANT. THUS, THERE WAS A SURGICAL DELAY OF ABOUT 30 MINUTES. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN T-PAL INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8698068 ↗
• InjuryJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY, THE SURGEON PERFORMED L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TILF) USING THE INSIGHT TUBES FOR ACCESS. AFTER INSERTING AN UNKNOWN 10 MM SPREADER/SHAVER, THE SURGEON WAS SATISFIED WITH THE RESULT OF LATERAL X-RAY AND STARTED TO INSERT A SMALL 10 MM TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) TRIAL. AFTER A FEW IMPACTIONS, THE SURGEON TOOK A LATERAL X-RAY AND NOTED THAT THE TRIAL LOOKED LIKE TURNING IN SPITE OF BEING IN LOCKED POSITION WHERE IN THE TIP OF THE TRIAL HAD BARELY PASSED INTO THE ENDPLATES. AFTER ANOTHER IMPACTION, THE CAGE CONTINUED TO APPEAR TURNING. THE SURGEON NOTED THAT THERE WAS A PLAY BETWEEN AN INSERTER/APPLICATOR OUT SHAFT AND THE TRIAL. SO, THE TRIAL WAS REMOVED AND THE CONNECTION WAS INSPECTED, ALTHOUGH IT DID NOT APPEAR TO BE LOOSENED. THEN, THE TRIAL WAS TIGHTENED AS FAR AS IT WENT THROUGH IN THE CLOSED POSITION, AND THE CONNECTION WAS INSPECTED AND FIRM. ON THE FIRST IMPACTION, THE T-PAL TRIAL WAS STRAIGHT, AND THE SURGEON DELIVERED A FEW MORE IMPACTIONS BUT THE CAGE AGGRESSIVELY TURNED BACK INTO THE CANAL, THUS, THE

  Patient problems: No Code Available

  MAUDE report 8672857 ↗
• MalfunctionSep 25, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, IT WAS DETERMINED THAT THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) TRIAL IMPLANT DOES NOT FIT THE INSTRUMENT. IT WAS THEN NOTED THAT THE END OF THE DEVICE WAS BROKEN. THE DEVICE WAS NOT USED. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906988 ↗
• MalfunctionSep 24, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SPINE SURGERY PERFORMED ON (B)(6) 2018, IT WAS DETECTED THAT T-PAL TRIAL SPACER DOES NOT FIT IN THE INSTRUMENT FOR TRIAL. IT WAS THEN DISCOVERED THAT T-PAL TRIAL SPACER WAS BROKEN. IT IS UNKNOWN WHEN AND WHERE THE DEVICE BROKE. NO CONTACT WITH PATIENT AND NO PATIENT HARM REPORTED. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903249 ↗
• MalfunctionDec 29, 2016Break; Break

  IT WAS REPORTED THAT A TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR SPACER SYSTEM (T-PAL) TRIAL SPACER AND A T-PAL SPACER APPLICATOR INNER SHAFT BROKE DURING A L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE ON (B)(6) 2016. THE VERY DISTAL END, ROUNDED PIECE OF THE INSERTER SHAFT BROKE OFF INSIDE THE T-PAL SPACER APPLICATOR HANDLE (APPLICATOR KNOB) WHILE BEING IMPACTED DURING IMPLANTATION. THE SAME PIECE BROKE ON THE TRIAL INSERTER. THAT IS THE ONLY SPOT IT BROKE, AND IT WAS ONLY A ONE PIECE BREAKAGE. THE T-PAL SPACER APPLICATOR HANDLE BECAME STRIPPED WITH THE THREADS STILL ATTACHED, AND IT APPEARED DULL. THE APPLICATOR KNOB THEN WASN'T ABLE TO THREAD ON. ALL FRAGMENTS WERE EASILY RETRIEVED. NOTHING WAS LEFT BEHIND IN THE PATIENT. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6212680 ↗