T-PAL 03.812.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10705034727790), received between Aug 25, 2015 and Jun 30, 2025 — classified as 14 injuries, 138 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 152 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 22366538 ↗
• MalfunctionOct 9, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING INSPECTION OF A SET BY ORTHOKIT EMPLOYEES THERE WAS BREAKDOWN NOTED. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409527 ↗
• MalfunctionDec 28, 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 REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. 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 18411201 ↗
• 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 INNER SHAFT. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17488012 ↗
• MalfunctionAug 9, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity 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 INNER SHAFT. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487758 ↗
• MalfunctionMar 28, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, INTRA OPERATIVELY BOTH THE TORQUE X25 DRIVERS WERE WORN AT THE DISTAL END, WHICH GIVE WAY AND SLIP WHEN TIGHTENED. TPAL INNERSHAFT WAS HIDDEN IN AT HOOK AT THE DISTAL END, THAT CAUSES THE CAGE TO LOOSEN DURING INSERTION AND TURN BEFORE IT SHOULD. THIS REPORT IS FOR ONE (1) MOSS MIAMI SPINE SYSTEM HEXLOBE DRIVER 5.5 X25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630772 ↗
• MalfunctionMar 28, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY THE DEVICES SEEMS NOT WORKING CORRECTLY. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629547 ↗
• MalfunctionMar 28, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY THE DEVICES SEEMS NOT WORKING CORRECTLY. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629546 ↗
• MalfunctionMar 28, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY THE DEVICES SEEMS NOT WORKING CORRECTLY. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629544 ↗
• MalfunctionMar 3, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE ASSEMBLY OF T-PAL INSERTER CONSTRUCT, APPLICATOR INNER SHAFT WAS NOT SEATING CORRECTLY IN THE OUTER SLEEVE. IT WAS REMOVED AND NOTICED BALL ON THE PROXIMAL END OF THE SHAFT HAS SNAPPED OFF. THERE WAS NO EVIDENCE OF THIS PIECE OF METAL IN THE TRAY OR IN THEATRE, AND COULD HAVE OCCURRED DURING CLEANING OR DURING DISASSEMBLY IN A PREVIOUS SURGERY BUT NOTICED TODAY. THERE WERE NO ISSUES NOTICES TODAY AS USED THE OTHER INNER SHAFT ON THE TRAY AND WILL CONTINUE TO USE THE OTHER INSERTER UNTIL DAMAGED INSERTER SHAFT CAN BE REPLACED. THIS REPORT IS FOR ONE (1) APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479640 ↗
• MalfunctionFeb 27, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16447882 ↗
• 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 INNER SHAFT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801549 ↗
• MalfunctionFeb 23, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION (L4/5) FOR TREATING VERTEBRAL CANAL STENOSIS ON (B)(6) 2022. THE SURGEON DEPLOYED THE IMPLANT WITH THE HELP OF A HAMMER. NEXT, THE SURGEON TRIED TO DETACH THE APPLICATOR INNER SHAFT, HOWEVER, BOTH TIGHTLY STUCK TOGETHER AND WERE NOT ABLE TO BE SEPARATED. THE SURGEON PREPARED A REPLACEMENT APPLICATOR INNER SHAFT AND AN IMPLANT AND COMPLETED THE REST OF THE PROCEDURE WITHOUT SURGICAL DELAY. THE SURGEON LATER CONFIRMED THAT HE DID NOT APPROPRIATELY CONNECT THE APPLICATOR INNER SHAFT IN QUESTION AND THE IMPLANT. PATIENT WAS STABLE. THIS REPORT IS FOR A T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587870 ↗
• MalfunctionSep 23, 2021Material Integrity Problem; Material Integrity Problem

  THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518330 ↗
• 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 INNER SHAFT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510272 ↗
• MalfunctionAug 6, 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 INNER SHAFT THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287172 ↗
• MalfunctionJul 15, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, DURING A PROCEDURE THE IMPLANT HOLDER WAS DETACHED FROM IMPLANT DURING INSERTION, WITHOUT LOOSENING IMPLANT HOLDER. THERE WAS SURGICAL DELAY OF (10) MINUTES. THE IMPLANT WAS CONFIRMED TO BE IN PLACE WITH THE USE OF IMAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT INVOLVES (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172467 ↗
• MalfunctionJul 9, 2021Material 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, THE INNER SHAFT OF THE APPLICATOR WAS BROKEN. THE END PIECE REMAINED IN THE KNOB AND WAS UNABLE TO BE REMOVED. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WAS NO PATIENT OR SURGICAL IMPACT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144815 ↗
• MalfunctionJul 9, 2021Material 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, THE INNER SHAFT OF THE APPLICATOR WAS BROKEN. THE END PIECE REMAINED IN THE KNOB AND WAS UNABLE TO BE REMOVED. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WAS NO PATIENT OR SURGICAL IMPACT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 4 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144731 ↗
• 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 INNER SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033131 ↗
• 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 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 SPACER APPLICATOR INNER SHAFT. THIS REPORT IS 2 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866977 ↗
• MalfunctionMar 11, 2021Compatibility 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. ONE (1) T-PAL TRIAL SPACER AND ONE (1) APPLICATOR INNER SHAFT WERE ALSO UNABLE TO ASSEMBLE. 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 REPORT IS FOR ONE (1) APPLICATOR INNER SHAFT. THIS IS REPORT 8 OF 8 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462485 ↗
• 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); APPLICAT OUT SHAFT (PART NUMBER 03.812.001, LOT UNKNOWN,

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11404754 ↗
• 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 OUTER SHAFT (PART # 03.812.001, 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 INNER SHAFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197793 ↗
• 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 INNER SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003390 ↗