T-PAL 03.812.307Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034727820), received between Mar 30, 2017 and Jun 4, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 7MM HEIGHT THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459906 ↗
• MalfunctionFeb 10, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 18, 2023, THE TRIAL CAGE IS SO WORN AT THE EDGE FACING THE INSERTER THAT IT IS NOT POSSIBLE TO TIGHTEN IT ARROW TO ARROW. THIS CAUSES IT TO TURN WHEN INSERTED BEFORE IT IS SUPPOSE TO, EVEN IF IT IS IN THE LOCKED POSITION. THE SURGERY TIME WAS EXTENDED AS A DIRECT RESULT OF INCIDENT FOR 10-15 MINUTES. A NEW ONE WAS USED. THIS REPORT IS FOR ONE (1) T-PAL SMALL TRIAL IMPLANT SIZ 7 NON DETA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353142 ↗
• MalfunctionApr 29, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON USED THE TRIAL WITH THE APPLICATOR. WHILE TRYING TO REMOVE THE TRIAL IMPLANT FROM THE DISK SPACE THE TRIAL DETACHED FROM THE APPLICATOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 5 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) T-PAL TRIAL SPACER 10MM X 28MM 7MM HEIGHT. THIS REPORT IS 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748830 ↗
• MalfunctionJan 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) TRIAL SPACER STYLET BROKE WHEN TIGHTENED AND BEING INSERTED TO THE T-PAL SPACER APPLICATOR KNOB. A BACKUP WAS AVAILABLE AND USED. THE APPLICATOR KNOB IS NOW NOT FUNCTIONING WITH THE BROKEN STYLET INSIDE. THE TRIAL WAS NEVER INSERTED INTO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8223816 ↗
• MalfunctionApr 9, 2018Break; Break

  IT WAS REPORTED DURING A FUSION PROCEDURE AT UNKNOWN LEVELS, SURGEON WAS ATTEMPTING TO PRY OPEN THE FUSED INNER BODY BY HAMMERING IN THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) 7MM TRIAL SPACER WITH THE T-PAL APPLICATOR WHEN THE DISTAL TIP OF THE TRIAL SPACER BROKE. SURGEON EVENTUALLY GAVE UP ATTEMPTING TO PRY OPEN THE INNER BODY. THE BROKEN TIP REMAINED STUCK IN THE T-PAL APPLICATOR. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 1 MINUTES. PATIENT REPORTED IN GOOD CONDITION. CONCOMITANT DEVICES REPORTED: T-PAL SPACER APPLICATOR KNOB (03.812.004, LOT 9850495, QUANTITY 1), T-PAL SPACER APPLICATOR HANDLE (03.812.001, LOT NUMBER UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7408371 ↗
• InjuryApr 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGERY FOR SPONDYLOLISTHESIS WAS PERFORMED BY USING THE T-PAL SYSTEM. THE FIXED AREA WAS L4 ¿ L5. WHILE THE T-PAL TRIAL WAS BEING USED AFTER IT WAS ASSEMBLED, THE LOCK OF THE TRIAL WAS DETACHED, AND ITS TIP MOVED. SINCE THE SURGEON THOUGHT INITIALLY THIS WAS DUE TO LOOSENED KNOB, THE T-PAL TRIAL WAS RE-ASSEMBLED; HOWEVER, THE LOCK DID NOT WORK. WHEN CHECKED BY REMOVING THE INNER CYLINDER, THE TIP OF THE T-PAL TRIAL HAD BEEN BROKEN. ANOTHER T-PAL TRIAL DIFFERENT IN SIZE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED WITH A DELAY (LESS THAN 30 MINUTES), AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7394239 ↗
• MalfunctionMar 30, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT LEVELS L3-S1 FOR DEGENERATIVE DISC DISEASE. AS THE SURGEON WAS USING THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) CAGE SYSTEM, HE EXPERIENCED SEVERAL ISSUES. THE FIRST ISSUE OCCURRED AS THE SURGEON WAS TRIALING AT L3-4. AFTER HE PUT THE TRIAL SPACER IN AND REMOVED IT, HE NOTICED THAT IT KEPT COMING UNTHREADED AND THEN EVENTUALLY, HE NOTICED THE TIP OF THE TRIAL SPACER HAD BECOME STUCK IN THE APPLICATOR KNOB AND SHEARED OFF. IT WAS REPORTED THAT ONCE THE TRIAL SPACER BROKE, THE SURGEON WAS NOT ABLE TO GET THE APPLICATOR KNOB TO TURN. THE TIP OF THE TRIAL SPACER REMAINS WEDGED IN THE APPLICATOR KNOB. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO GET AN IDEA OF THE HEIGHT OF THE IMPLANT EVEN THOUGH THE TRIAL SPACER WAS BROKEN. THE NEXT ISSUE HAPPENED AS THE SURGEON WAS USING THE INNER SHAFT TO INSERT THE 7MM T-PAL SPACER AND THE TIP OF THE INNER SHAFT BECAME STUCK IN A SECOND APPLICATOR KNOB AND SHEARED OFF. THE TIP OF THE INNER SHAFT REMAINS WEDGED IN THAT APPLICATOR KNOB. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO GET THE IMPLANT HALFWAY IN AND TIGHTENED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6448694 ↗