T-PAL 03.812.521Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10705034821085), received between Jan 10, 2019 and Oct 14, 2024 — classified as 8 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (24 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A TLIF (L5/S1) FOR LUMBAR CANAL STENOSIS ON (B)(6) 2024. DURING SURGERY, THE SURGEON FILLED GRAFTED BONE AFTER DISC DISSECTION AND INSERTED THE CAGE AS PER TECHNIQUE USING AN INSERTER. WHEN THE TIP OF THE INSERTER WAS BEYOND THE POSTERIOR WALL OF THE VERTEBRAL BODY, THE SALES REP INFORMED THE SURGEON TO TURN THE KNOB TO THE LEFT TO THE POINT WHERE IT STOPPED BEFORE PERFORMING THE ROTARY OPERATION. IT WAS CONFIRMED THAT THE CAGE WAS PLACED IN THE OPTIMAL POSITION WHEN THE IMAGE WAS CHECKED AT THE SIDE AND FRONT OF THE IMAGE. THE SURGEON ATTEMPTED TO REMOVE THE INSERTER, HOWEVER, WAS UNABLE TO REMOVE IT FROM THE CAGE. THEREFORE, LEAVING ONLY THE SHAFT, THE SURGEON REMOVED THE INSERTER BODY FROM THE CAGE. THE SHAFT COULD NOT BE REMOVED, AFTER CHANGING THE ANGLE AT WHICH THE SHAFT WAS HELD SIGNIFICANTLY, IT COULD FINALLY BE REMOVED. WHEN CHECKED OUTSIDE THE SURGICAL FIELD, THE TIP OF THE SHAFT WAS FOUND TO BE SEVERELY BENT AND DEFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20442010 ↗
• MalfunctionJul 10, 2024Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713578 ↗
• MalfunctionApr 2, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON MARCH 16, 2024, THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) INSERTER WAS REMOVED FROM THE CAGE. THE INSERTER WAS FINALLY DISCONNECTED FROM THE CAGE WITH THE SLAP HAMMER. THERE WAS NO IMPACT ON THE PATIENT AND CAGE POSITIONING, HOWEVER THE T-PAL INSERTER IS DAMAGED. THE STEM IS ALL TORN AND THE ACTUAL INSERTER IS DYSFUNCTIONAL. THERE WAS NO SIGNIFICANT DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T-PAL ADVANCED APPLICATOR INNER SHAFT THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021023 ↗
• MalfunctionFeb 15, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE INNER SHAFT IN QUESTION WAS DISFORMED DURING THE SURGERY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADVANCED APPL INNER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710660 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

  ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268317 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

  THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268157 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

  THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267870 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED T-PAL HOLDERS NO LONGER HOLD THE CAGE PROPERLY. NO PATIENT HARM. THIS REPORT IS FOR T-PAL ADVANCED APPLICATOR INNER SHAFT FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266810 ↗
• MalfunctionNov 15, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TPAL APPLICATOR INNER SHAFT TOP TIP WAS BROKEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139215 ↗
• MalfunctionSep 6, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION ON AUGUST 22, 2023, THE SALES REPRESENTATIVE NOTICED DEFORMITY OF THE T-PAL INNER SHAFT. PATIENT WAS STABLE. THIS REPORT IS FOR A T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692263 ↗
• MalfunctionMay 18, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, AFTER THE T-PAL CAGE (TI) WAS POSITIONED BETWEEN THE VERTEBRAL BODIES L5-S1, THE SURGEON DECIDED TO TAKE THE TLIF CAGE BACK A LITTLE BIT ¿ AS THE CAGE CAME TO LIE A LITTLE TIGHTLY AGAINST THE ANTERIOR PLATE. THE CAGE WAS ALREADY ROTATED BY 90° AT THIS TIME. WHEN STRIKING BACK THE ADVANCED APPLICATOR, THE WELL-FITTING IMPLANT HAS DETACHED FROM THE INSTRUMENT. THE CAGE COULD NO LONGER BE GRASPED WITH THE REMOVAL INSTRUMENT. THE CAGE IS POSITIONED AT THE ANTERIOR END PLATE. THERE WAS NO FIXATION WITH DORSAL SCREWS, AS PLANNED. THERE WAS A SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT INVOLVES ONE (1) T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954762 ↗
• MalfunctionMay 9, 2023Compatibility Problem; Compatibility Problem

  THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894667 ↗
• MalfunctionMar 27, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE EVENT OCCURRED DURING AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2023. AFTER A CAGE WAS ROTATED, THE SURGEON TRIED TO REMOVE THE CAGE FROM THE SHAFT BUT COULDN¿T. THEREFORE, THE SURGEON DETACHED THE SHAFT FROM A HANDLE AND THEN TRIED TO REMOVE THE CAGE FROM THE SHAFT. SINCE THE ATTEMPT FAILED, THE SURGEON ATTACHED THE SHAFT AND THE HANDLE AGAIN. THE TIP OF THE SHAFT BECAME BENT BECAUSE THE SURGEON FORCIBLY ATTACHED THE SHAFT AND THE HANDLE. THIS EVENT DID NOT AFFECT DURATION OF SURGERY AND THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619904 ↗
• MalfunctionFeb 22, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED: INSTRUMENTS ARE BENT HAVE JAMMED AND CAN NOT BE DISASSEMBLED. NO SURGERY DELAY AND THERE IS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) ADVANCED APPL INNER SHAFT THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417850 ↗
• MalfunctionFeb 14, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE KNOB WAS TURNED IN THE OPEN DIRECTION AND THE T-PAL WAS TURNED, IT HAD STRONG RESISTANCE BETWEEN THE INNER SHAFT TIP AND THE T-PAL. THERE WAS NO EFFECT ON A PATIENT; THIS EVENT OCCURRED AT A T-PAL WORKSHOP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371436 ↗
• MalfunctionJan 12, 2023Compatibility Problem; Compatibility Problem

  HOLD FOR RH 1.17 DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TPAL INSTRUMENTS WERE DEFECTIVE POSTOPERATIVELY. THE INNER SHAFT CANNOT BE FULLY INSERTED INTO THE OUTER SHAFT. NO PATIENT HARM OR SURGICAL DELAY WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16149129 ↗
• MalfunctionJan 12, 2023Compatibility Problem; Compatibility Problem

  LOG. DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TPAL INSTRUMENTS WERE DEFECTIVE POSTOPERATIVELY. THE INNER SHAFT CANNOT BE FULLY INSERTED INTO THE OUTER SHAFT. NO PATIENT HARM OR SURGICAL DELAY WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148684 ↗
• MalfunctionDec 19, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TLIF (L5 TO S1) FOR LUMBAR SPINAL CANAL STENOSIS. THE IMPLANT WAS INSERTED INTO THE INTERBODY WITH THE ADVANCED APPLICATOR, COMBINING THE ADVANCED APPLICATOR INNER SHAFT, THE ADVANCED APPLICATOR OUTER SHAFT, AND THE APPLICATOR KNOB. WHEN THE APPLICATOR WAS REMOVED AFTER INSERTING THE IMPLANT IN PROPER POSITION, THE ADVANCED APPLICATOR INNER SHAFT AND THE IMPLANT WERE STUCK AND COULD NOT BE REMOVED. THE ADVANCED APPLICATOR OUTER SHAFT AND THE APPLICATOR KNOB WERE REMOVED FIRST. THEN THE ADVANCED APPLICATOR INNER SHAFT WAS REMOVED CAREFULLY. HOWEVER, THE TAPERED TIP OF THE ADVANCED APPLICATOR INNER SHAFT WAS DEFORMED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007245 ↗
• MalfunctionOct 20, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SPINAL FUSION FOR THE LUMBER VERTEBRAE HERNIATED DISK, THE INNER SHAFT OF THE INSTRUMENT BENT. THE STAG-SHAPED TIP OF THE INNER SHAFT HAS BEEN OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638356 ↗
• MalfunctionJun 2, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM HUNGARY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON MAY 18, 2022, A T-PAL APPLICATOR INNER SHAFT WAS FOUND BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A T-PAL ADVANCED APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577347 ↗
• MalfunctionJan 4, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON REPORTS 3 IDENTICAL CASES. THIS CAPTURES CASE 3: AFTER THE SURGEON HAD PLACED THE CAGE HE WANTED TO ADJUST THE PLACING OF THE CAGE. WHILE DOING SO THE INSERTER REMOVED ITSELF FROM THE CAGE. SURGEON STATES THAT THE INSERTER WAS DEFINITELY NOT UNLOCKED AND THE GREEN RING WAS VISIBLE. THE CAGE HAD THEN BE REMOVED WITH THE REVISION PLIERS. NO ALLEGATION AGAINST THE REVISION PLIERS. THIS REPORT IS FOR ONE (1) ADVANCED APPL INNER SHAFT. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158115 ↗
• MalfunctionJan 4, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON REPORTS 3 IDENTICAL CASES. THIS CAPTURES CASE 3: AFTER THE SURGEON HAD PLACED THE CAGE HE WANTED TO ADJUST THE PLACING OF THE CAGE. WHILE DOING SO THE INSERTER REMOVED ITSELF FROM THE CAGE. SURGEON STATES THAT THE INSERTER WAS DEFINITELY NOT UNLOCKED AND THE GREEN RING WAS VISIBLE. THE CAGE HAD THEN BE REMOVED WITH THE REVISION PLIERS. NO ALLEGATION AGAINST THE REVISION PLIERS. THIS REPORT IS FOR ONE (1) ADVANCED APPL INNER SHAFT. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158107 ↗
• MalfunctionJan 4, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON REPORTS 3 IDENTICAL CASES. THIS CAPTURES CASE 2: AFTER THE SURGEON HAD PLACED THE CAGE HE WANTED TO ADJUST THE PLACING OF THE CAGE. WHILE DOING SO THE INSERTER REMOVED ITSELF FROM THE CAGE. SURGEON STATES THAT THE INSERTER WAS DEFINITELY NOT UNLOCKED AND THE GREEN RING WAS VISIBLE. THE CAGE HAD THEN BE REMOVED WITH THE REVISION PLIERS. NO ALLEGATION AGAINST THE REVISION PLIERS. THIS REPORT IS FOR ONE (1) ADVANCED APPL OUTER SHAFT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156435 ↗
• MalfunctionJan 4, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON REPORTS 3 IDENTICAL CASES WHICH CAPTURES 1- AFTER THE SURGEON HAD PLACED THE CAGE HE WANTED TO ADJUST THE PLACING OF THE CAGE. WHILE DOING SO THE INSERTER REMOVED ITSELF FROM THE CAGE. SURGEON STATES THAT THE INSERTER WAS DEFINITELY NOT UNLOCKED. THE GREEN RING WAS VISIBLE AND CAGE HAD THEN BE REMOVED WITH THE REVISION PLIERS. NO ALLEGATION AGAINST THE REVISION PLIERS. THIS REPORT IS FOR ONE (1) APPLICATOR KNOB. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155693 ↗
• MalfunctionNov 17, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, AFTER IMPLANTATION OF THE TRIAL IMPLANT THE FRONT PART OF THE ADVANCED APPLICATOR OUTER SHAFT BROKE OFF. NO FRAGMENTS WERE GENERATED. THE TRIAL IMPLANT WAS REMOVED. THE OUTER SHAFT AND INNER PART OF THE TRIAL IMPLANT CAN NO LONGER BE REMOVED. ADDITIONALLY, TWO (2) ADVANCED APPLICATOR INNER SHAFTS BROKE OFF AT THE REAR END IN THE TAPER BALL CONNECTION AREA. ANOTHER SET OF INSTRUMENTS WAS AVAILABLE TO USE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) ADVANCED APPL INNER SHAFT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831637 ↗