T-PAL 03.812.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10705034727783), received between Jan 4, 2017 and Dec 29, 2023 — classified as 10 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (18 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 19, 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 HANDLE. 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 18416670 ↗
• MalfunctionSep 27, 2023Use of Device Problem; Compatibility Problem; Use of Device Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY WITH TPAL PRODUCTS PERFORMED ON (B)(6) 2023. DURING SURGERY, THE CAGE COULD NOT BE RELEASED FROM THE HOLDER. IN THE SURGERY, THE CAGE WAS ATTACHED TO THE HOLDER AND INSERTED PROPERLY. THE LOCK WAS RELEASED AND THE PREPARATION FOR THE ROTATION WAS DONE ACCORDING TO THE SURGICAL TECHNIQUE. AFTER THAT, THE SURGEON HAMMERED AND CONFIRMED THAT THE CAGE WAS PLACED IN THE PROPER POSITION. THE SURGEON THEN TRIED TO RELEASE THE CAGE FROM THE HOLDER, BUT THE DIAL OF THE HOLDER COULD NOT BE TURNED, AND THE CAGE COULD NOT BE RELEASED. THEREFORE, THE SURGEON OPENED AND USED ANOTHER NEW CAGE AND HOLDER BECAUSE THE SURGEON THOUGHT THE EVENT MIGHT HAVE BEEN CAUSED BY AN OPERATIONAL ERROR. THE NEW CAGE WAS PLACED AND RELEASED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES SPINE): INSTRUMENT/HOLDER. (B)(4) (DEPUY SPINE): CAGE. THIS REPORT IS FOR ONE (1) APPLICAT OUT SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17824792 ↗
• MalfunctionJan 26, 2023Compatibility Problem; Compatibility Problem

  THE EQUIPMENT WAS NOT USED IN SURGERY; THE FAULT WAS DISCOVERED WHILE DOING A WORKSHOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246247 ↗
• MalfunctionJan 23, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT THE INSERTER HAS A BENT HOOK, WHICH BENDS OUT LATERALLY IN THE DISTAL PART. THIS IS DANGEROUS IN RELATION TO INTRODUCING THE INSTRUMENT INTO THE PT. IT IS SOMEWHAT UNCERTAIN WHEN AND HOW THIS HAPPENED DURING SURGERY. WHEN IT WAS DISCOVERED, THEY SWITCHED TO THE OTHER INSERTER ON THE SET. THE SURGERY TIME WAS EXTENDED FOR 15-20 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO INJURY TO THE PATIENT AT THE MOMENT. THIS REPORT IS FOR ONE (1) APPLICAT OUT SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224935 ↗
• MalfunctionJan 12, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 8, 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 HANDLE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148704 ↗
• MalfunctionJan 12, 2023Compatibility Problem; Compatibility Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148693 ↗
• MalfunctionJan 12, 2023Compatibility Problem; Compatibility Problem

  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. THIS REPORT INVOLVES ONE T-PAL ADVANCED APPLICATOR HANDLE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148680 ↗
• MalfunctionMar 17, 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 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 HANDLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801483 ↗
• MalfunctionSep 21, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING ONE LEVER TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) CAGE PROCEDURE ON (B)(6) 2021, THE INNER SHAFT COULD NOT BE REMOVED FROM THE OUTER SHAFT. IT IS STUCK INSIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE OTHER ONE ON THE SET. THERE WAS A SURGICAL DELAY OF TEN TO FIFTEEN (10-15) MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR HANDLE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510268 ↗
• MalfunctionAug 4, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, AFTER THE DISC PREP, SURGEON PROCEEDED ON TO TESTING OUT THE TRIALS AND NOTICED THAT THE TRIAL CAGE STARTED TURNING AS HE WAS HAMMERING IT IN EVEN BEFORE HIM TURNING THE KNOB ON THE INSTRUMENT. IT WAS RESOLVED BY USING A DIFFERENT TRIAL AND APPLICATOR INSTRUMENT. THE CASE WAS FINISHED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) T-PAL SPACER APPLICATOR HANDLE THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276301 ↗
• MalfunctionJun 21, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE PROCEDURE THE SURGEON COULD NOT OPEN THE IMPLANT HOLDER. AFTER A FEW TURNS, THE KNOB BECAME STUCK ON THE APPLICATOR OUTER SHAFT AND IT TOOK A LOT OF FORCE TO OPEN IT. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033084 ↗
• MalfunctionJun 10, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AT THE DISTAL TIP THERE WERE MARKINGS THAT MADE IT DIFFICULT TO INSERT THE INNER SHAFT AND TRIAL IMPLANT. THE ALIGNMENT GUIDE HAD A DEFECT IN THE DISTAL PART AND THE CEMENT CANNULA WOULD NOT GO THROUGH IT. THE ISSUE WAS IDENTIFIED DURING PRE-OP. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975732 ↗
• MalfunctionJun 10, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AT THE DISTAL TIP THERE WERE MARKINGS THAT MADE IT DIFFICULT TO INSERT THE INNER SHAFT AND TRIAL IMPLANT. THE ALIGNMENT GUIDE HAD A DEFECT IN THE DISTAL PART AND THE CEMENT CANNULA WOULD NOT GO THROUGH IT. THE ISSUE WAS IDENTIFIED DURING PRE-OP. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975692 ↗
• 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 ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS REPORT IS 2 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748799 ↗
• InjuryMar 3, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE CAGE DISENGAGED FROM THE APPLICATOR. THE SURGEON INSERTED APPLICATOR WITH A 9MM PRO-TI CAGE. A STANDARD PROCEDURE WAS FOLLOWED, THE CAGE WAS FIRST INSERTED IN A LOCKING STATE, THEN THE KNOB WAS TURNED TO OPEN FOR TURNING THE CAGE. THE POSITION OF THE CAGE WAS SLIGHTLY ANTERIOR. THE SURGEON DECIDED TO USE A SLIDE HAMMER TO MOVE THE CAGE IN POSTERIOR DIRECTION. THE SLIDE HAMMER WAS OPERATED IN A GENTLE AND CONTROLLED FORCE. THE CAGE DETACHED FROM THE APPLICATOR. A REMOVAL TOOL WAS USED TO THE GRAB THE IMPLANT, BUT THERE WAS NOT ENOUGH SPACE TO INSERT THE REMOVAL TOOL. THE DISENGAGED IMPLANT WAS REMOVED FROM ANTERIOR APPROACH THROUGH ANOTHER INCISION. SYNFIX EVOLUTION WAS USED TO FUSE L5-S1. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: IMPACTION INSTRUMENTS: HAMMER/MALLET (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1) EXTRACTION INSTRUMENTS: UNIVERSAL SCREW REMOVAL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1) APPLICATOR INNER SHAFT (PART NUMBER 03.812.003, LOT UNKNOW

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11404796 ↗
• MalfunctionJan 19, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) CAGE DELIVERY DEVICE WOULD NOT DETACH FROM THE CAGE. SURGEON HAD TO TRY DISENGAGE THE INNER SHAFT AND THAT RELEASED ENOUGH TO RELEASE THE CAGE BUT STILL WOULD NOT COME OUT FULLY. THE INNER SHAFT IS STILL STUCK INSIDE THE CAGE DELIVERY DEVICE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: APPLICATOR INNER SHAFT (PART # 03.812.003, LOT # UNKNOWN, QUANTITY 1), APPLICATOR KNOB (PART # 03.812.004, LOT # UNKNOWN, QUANTITY 1), CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197789 ↗
• MalfunctionDec 22, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, THE APPLICATOR SHAFT AND KNOB BLOCKED WHEN TIMING UP AND IN TO PREPARE FOR THE PICK-UP OF THE INNER SHAFT. THE SURGERY WAS COMPLETED WITHOUT DELAY. NO ADVERSE PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) T-PAL SPACER APPLICATOR HANDLE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057079 ↗
• InjuryDec 17, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE T-PAL IMPLANT KINKED WHEN IT WAS KNOCKED INTO THE DISC SPACE FROM AN UNKNOWN T-PAL INSERTER. BECAUSE OF A DURAL LEAKAGE AND SCARRING FROM A FORMER OPERATION, THE USER HAS GIVEN A SLIGHTLY LATERAL ANGLE. IT WAS REPORTED THAT THE PATIENT ALSO HAD HARD BONES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER T-PAL INSERTER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPLANT INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Cerebrospinal Fluid Leakage; Unspecified Tissue Injury

  MAUDE report 11027212 ↗
• MalfunctionDec 14, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING SURGERY PREPARATION, THE T-PAL INSERTER CAME APART. NO SURGICAL INVOLVEMENT WAS REPORTED. NO PATIENT INVOLVEMENT. THE UNKNOWN PROCEDURE WAS COMPLETED WITH ANOTHER AVAILABLE INSTRUMENT. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003397 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: Injury

  MAUDE report 10791975 ↗
• MalfunctionOct 7, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT IT WAS NOT POSSIBLE TO INSERT THE APPLICATOR INTO THE INNER SHAFT. AT THE DISTAL END OF THE APPLICATOR WHERE THE INNER SHAFT OR TRIAL IS INSERTED, THE SIDES WERE BENT INWARDS SO THAT IT IS NOT POSSIBLE TO INSERT THE INNER SHAFT. IT IS WHERE THE TRIALCAGE OR THE IMPLANT HITS THE APPLICATOR WHEN INSERTING IN THE PATIENT AND WHEN TURNING THE IMPLANT. CONCOMITANT DEVICE: UNKNOWN INNER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10643537 ↗
• MalfunctionSep 28, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE TIPS OF THE APPLICATORS WERE BENT. AS A RESULT, THE T-PAL CAGES COULD NOT BE FIXATED PROPERLY. THERE WAS NO IMPACT TO SURGERY OR PATIENT. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10592941 ↗
• MalfunctionSep 28, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE TIPS OF THE APPLICATORS WERE BENT. AS A RESULT, THE T-PAL CAGES COULD NOT BE FIXATED PROPERLY. THERE WAS NO IMPACT TO SURGERY OR PATIENT. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10592919 ↗
• MalfunctionAug 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES: UNKNOWN MATRIX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) UNKNOWN CAGE/SPACERS: T-PAL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408785 ↗
• MalfunctionAug 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES: UNKNOWN MATRIX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). UNKNOWN CAGE/SPACERS: T-PAL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408780 ↗