T-PAL 03.812.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10705034821078), received between Jan 10, 2019 and Jul 10, 2024 — classified as 8 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713459 ↗
• MalfunctionApr 15, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A TLIF FOR A DEGENERATION ON (B)(6) 2024. WHEN THE APPLICATOR KNOB AND ADVANCED APPL OUTER SHAFT WAS ASSEMBLED, BOTH PRODUCTS STUCK AND COULD NOT BE DETACHED. SUBSTITUTES WERE USED IN THE SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADVANCED APPL OUTER SHAFT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19108171 ↗
• 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 (B)(6) 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 HANDLE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021207 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267706 ↗
• 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 18267443 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267036 ↗
• 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 18266639 ↗
• MalfunctionAug 9, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE SURGEON HAD DIFFICULTY INSERTING THE TPAL PROTEIN CAGE. CONSEQUENTLY, TWO OF THE TPAL INSERTER HANDLES AND STEMS NEEDED TO BE REPLACED. THE PATIENT WAS NOT IMPACTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490617 ↗
• MalfunctionAug 9, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE SURGEON HAD DIFFICULTY INSERTING THE TPAL PROTEIN CAGE. CONSEQUENTLY, TWO OF THE TPAL INSERTER HANDLES AND STEMS NEEDED TO BE REPLACED. THE PATIENT WAS NOT IMPACTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487958 ↗
• 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 HANDLE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954760 ↗
• MalfunctionMay 9, 2023Compatibility Problem; Compatibility Problem

  THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894611 ↗
• MalfunctionApr 10, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A DEMO AND ONE INSERTER LOST A METAL PIECE AND THE ANOTHER ADVANCED APPL OUTER SHAFT WAS NOT FUNCTIONING PROPERLY. NO PATIENT OR CASES WERE INVOLVED AND NO DELAYS WERE OBTAINED. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS FOR ONE (1) ADVANCED APPL OUTER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710251 ↗
• 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 OUTER SHAFT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417515 ↗
• MalfunctionMar 31, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SPINAL PROCEDURE THE ADVANCED APPLICATOR OUTER SHAFT WAS BLOCKED, AND IT WAS NOT POSSIBLE TO ATTACH OR DETACH ITSELF. THERE WAS NO SURGICAL DELAY. A SECOND APPLICATOR WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) ADVANCED APPLICATOR OUTER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965479 ↗
• 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 OUTER SHAFT. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158190 ↗
• 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 OUTER SHAFT. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158087 ↗
• 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 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156431 ↗
• 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 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155720 ↗
• MalfunctionNov 19, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS FOUND THAT THE APPLICATOR KNOB COULD NOT DISASSEMBLE FROM THE T-PAL ADVANCED APPLICATOR HANDLE. THERE WAS NO SURGICAL OR PATIENT IMPACT. THE ISSUE WAS FOUND POSTOPERATIVELY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846806 ↗
• 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 OUTER SHAFT. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831664 ↗
• MalfunctionAug 27, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE CLEANING PROCEDURE IT WAS NOTICED THAT THE INSTRUMENT CANNOT BE DISASSEMBLED. THERE WAS NO IMPACT TO PATIENT OR SURGERY. THIS REPORT INVOLVES ONE (1) T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377185 ↗
• InjuryJul 21, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A TLIF TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021. AFTER THE CAGE WAS DEPLOYED, THE SURGEON STARTED TURNING IT TO OBTAIN MORE APPROPRIATE POSITION WITH THE HELP OF A HAMMER. AS THE SURGEON TAPPED THE CAGE FORCEFULLY, IT BROKE OFF. THE SURGEON DECIDED TO LEAVE APPROXIMATELY HALF THE CAGE IN THE PATIENT'S BODY. PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY (30) MINUTES DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER TREATMENT IS PLANNED. THE SURGEON SUGGESTED POSSIBLE CAUSES FOR THE EVENT: THE PATIENT HAD ROBUST BONE. SURGEON TURNED THE CAGE WHICH WAS DEPLOYED AT SLIGHTLY ANTERIOR POSITION COMPARED THE TRIAL IMPLANT. THIS REPORT IS FOR A T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12204302 ↗
• MalfunctionMay 25, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE ADVANCED APPLICATOR OUTER SHAFT WAS STUCK. THE IMPLANT WAS REMOVED EASILY BUT UNABLE TO UNASSEMBLED THE INSTRUMENT. THE SURGERY WENT WELL. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) IMPLANT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) T-PAL ADVANCED APPLICATOR HANDLE. THIS REPORT IS 4 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876295 ↗
• MalfunctionMay 21, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE ADVANCED APPLICATOR OUTER SHAFT WAS STUCK. THE IMPLANT WAS REMOVED EASILY BUT UNABLE TO UNASSEMBLED THE INSTRUMENT. THE SURGERY WENT WELL. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) IMPLANT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) T-PAL ADVANCED APPLICATOR HANDLE THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866781 ↗
• MalfunctionMar 18, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING SURGERY THERE WERE ISSUES IMPLANTING THE TPAL-CAGES BECAUSE THE APPLICATOR WAS BLOCKED. THE CAGE WAS PLACED WITH SOME DIFFICULTY AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE SURGICAL DELAY. CONCOMITANT DEVICES: UNKNOWN APPLICATOR KNOB (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN CAGE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515361 ↗