T-PAL 03.812.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10705034727806), received between Jan 4, 2017 and Jun 30, 2025 — classified as 15 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (40 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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PARTS FOR THE INSERTER IS SEIZED AND CAN NOT BE TAKEN APART. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367141 ↗
• MalfunctionApr 21, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THE KNOB OF THE INSTRUMENT GOT CAUGHT IN THE TRIAL CAGE AND CANNOT BE REMOVED. THERE WERE NO CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION/REVISION PROCEDURE REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 21871852 ↗
• MalfunctionJul 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) FOR SPONDYLOLISTHESIS ON (B)(6) 2024. IN THE SURGERY, WHEN THE SURGEON TURNED THE INSERTER DOWN TO ATTACH IT TO THE CAGE, IT FELL TO THE FLOOR WHERE THE SHAFT SLID STRAIGHT OUT. A NEW PRODUCT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE TIP OF THE HANDLE SIDE OF THE SHAFT WAS MISSING, WHICH REMAINED INSIDE THE HANDLE AND COULD NOT BE GRASPED AT ALL. IT IS UNKNOWN AT WHAT POINT THE BREAKAGE OCCURRED. PATIENT WAS STABLE. THIS REPORT IS FOR A T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 2 OF 3 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716087 ↗
• 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) T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19108137 ↗
• 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 SPACER APPLICATOR KNOB THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021030 ↗
• MalfunctionJan 11, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-PAL HOLDERS NO LONGER HELD THE CAGE PROPERLY. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 2 OF 2 FOR (B)(4) THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490874 ↗
• MalfunctionJan 11, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-PAL HOLDERS NO LONGER HELD THE CAGE PROPERLY. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490873 ↗
• MalfunctionJan 10, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-PAL HOLDERS NO LONGER HELD THE CAGE PROPERLY. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484058 ↗
• MalfunctionJan 10, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-PAL HOLDERS NO LONGER HELD THE CAGE PROPERLY. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS NOTED POSTOPERATIVELY. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 9 OF 10 FOR (B)(4) . THIS REPORT IS RELATED TO (B)(4) , WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484055 ↗
• MalfunctionDec 28, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS NOT POSSIBLE TO DISASSEMBLE THE APPLICATOR. THREE PARTS OF THE APPLICATOR OUTER SHAFT, INNER SHAFT AND APPLICATOR KNOB AS WELL AS A PROBE CAGE WERE TIGHTLY TOGETHER. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411494 ↗
• MalfunctionAug 14, 2023Compatibility Problem; Compatibility Problem

  PATIENT STATUS/ OUTCOME: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17543141 ↗
• 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 SPACER APPLICATOR KNOB. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490523 ↗
• 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 SPACER APPLICATOR KNOB. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487827 ↗
• MalfunctionJul 21, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CONTROL BUTTON ON THE DEVICE REMAINED PRESSED. THE OTHER APPLICATOR CONTROL HAD TO BE USED TO MOUNT THE TRIAL AND PLACE THE FINAL IMPLANT. THE PATIENT WAS NOT AFFECTED. THE INSTRUMENT ARRIVED THAT WAY AT SURGERY, AND AS IT WAS DAMAGED, IT WASN¿T USED. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372578 ↗
• MalfunctionJul 18, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, A PLIF (L-S) WAS PERFORMED FOR SPINAL STENOSIS. THE SURGEON HAMMERED THE HOLDER TO INSERT A CAGE INTO L5-S, BUT THE CAGE WAS NOT INSERTED SMOOTHLY. THEREFORE, THE SURGEON HAMMERED THE HOLDER HARD. HOWEVER, THE CAGE COULD NOT BE INSERTED PROPERLY. THE CAGE BECAME UNABLE TO REMOVE FROM THE HOLDER ¿ THE BUTTON FOR DISASSEMBLY DID NOT WORK PROPERLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344234 ↗
• MalfunctionMay 3, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING A WORKSHOP, THE APPLICATOR HANDLE IN QUESTION WAS FOUND TO WORK IMPROPERLY. THE HANDLE WOULD JAM AND WOULD NOT RELEASE DURING TESTING. THE TOOL WAS NOT USED DURING A PROCEDURE, THERE IS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR A T-PAL SPACER APPLICATOR KNOB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864775 ↗
• 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) APPLICATOR KNOB THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417844 ↗
• MalfunctionNov 17, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A BROKEN INSTRUMENT IN T-PAL SET WAS RECEIVED. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815480 ↗
• MalfunctionNov 17, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON OCTOBER 25, 2022, A BROKEN INSTRUMENT IN T-PAL SET WAS RECEIVED. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815476 ↗
• MalfunctionJun 22, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FINLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ADVANCED APPL OUTER SHAFT BECAME STUCK IN ONE OF THE APPLICATOR KNOBS AND COULD NOT BE USED IN THE SURGERY. THE OTHER KNOB HAD BIT OF THE SAME PROBLEM AND THE LOCKING RING BECAME STUCK AS WELL, THIS KNOB COULD BE USED, AND THE IMPLANT COULD BE PLACED IN THE PATIENT. THERE WAS NO DELAY TO THE SURGERY. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775873 ↗
• MalfunctionApr 12, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF PROCEDURE (L3-4) FOR TREATING DEGENERATIVE DISEASE ON (B)(6), 2022. THE APPLICATOR KNOB IN QUESTION WAS USED DURING THE PROCEDURE WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. IT WAS POSTOPERATIVELY CONFIRMED THAT THE APPLICATOR KNOB WAS NOT ABLE TO BE DETACHED FROM THE HANDLE. THE KNOB WAS TOO TIGHT TO TURN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE APPLICATOR KNOB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088344 ↗
• MalfunctionApr 7, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2022. THE SLIDING HAMMER OF THE T PAL SET CAN NO LONGER BE ATTACHED TO BOTH APPLICATOR KNOBS. SO THAT A KNOCK-OUT WITH THE SLIDING HAMMER IS NO LONGER FEASIBLE. THERE IS NO ALLEGATION AGAINST THE SLIDING HAMMER 03.809.972. THERE IS NO SURGERY IMPACT. THERE IS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044977 ↗
• MalfunctionApr 7, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SLIDING HAMMER OF THE T PAL SET CAN NO LONGER BE ATTACHED TO BOTH APPLICATOR KNOBS. SO THAT A KNOCK-OUT WITH THE SLIDING HAMMER IS NO LONGER FEASIBLE. THERE IS NO ALLEGATION AGAINST THE SLIDING HAMMER 03.809.972. THERE IS NO SURGERY IMPACT. THERE IS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1)T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044039 ↗
• MalfunctionMar 17, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SILVER BUTTON BECAME STUCK, AND THE SURGEON WAS UNABLE TO RELEASE THE CAGE. ANOTHER CAGE WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR KNOB. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801611 ↗
• 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) APPLICATOR KNOB. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158163 ↗