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EIT PLIF Inserter PET30101Recalls & reported problems

EIT Emerging Implant Technologies GmbH · T-Handle Inserter · Class 2

All models of EIT PLIF Inserter (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This EIT T-Handle Inserter is a surgical instrument used to place bone graft cages in the lumbar spine during fusion surgery. Most of the 31 reports describe the tool breaking, snapping off, or jamming while the cage was being inserted or hammered into place, sometimes leaving the cage stuck in the disc space or requiring the surgeon to pull it out by force; one report mentions a piece of the instrument left in the patient. There are no deaths and 1 injury, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
31
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04260397088388), received between Nov 13, 2019 and Aug 18, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break19
  • Device-Device Incompatibility11
  • Appropriate Device Problem Term/Code Not Available3
  • Detachment of Device or Device Component3
  • Material Twisted/Bent1
  • Mechanical Jam1

Patient problems

  • No Clinical Signs, Symptoms or Conditions24
  • No Consequences Or Impact To Patient4
  • Insufficient Information2
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 18, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

    IT WAS REPORTED THAT DURING A PROCEDURE, THE CONDUIT PLOT IMPLANT INSERTED WOULD NOT RELEASE THE CAGE. IT WAS CROSS THREADED WHEN INSERTED INSIDE HANDLE AS IT SNAPPED OFF AND WAS UNABLE TO RELEASE THE CAGE. THE CAGE WAS REMOVED, HANDLE CHANGED, AND A NEW CAGE WAS INSERTED WITH GOOD RESULTS. THERE WAS NO PATIENT CONSEQUENCE. PATIENT WAS DISCHARGED AS PLANNED. SURGERY WAS PROLONGED BY APPROXIMATELY TEN MINUTES. CAGE SIZE CHOSEN BY SURGEON LOADED ONTO PLIF T-HANDLE INSERTED WITHOUT ISSUE. CAGE PLACED UNDER X-RAY, DISTRACTION RELEASED AND WENT TO RELEASE CAGE FROM HANDLE BUT KNOB AT TOP OF INSERTED JUST SPINNING. EVENTUALLY IT GOT TIGHTER BUT SURGEON WAS UNABLE TO TURN BY HAND ANYMORE, AND THE CAGE WAS STILL NOT RELEASED. LOOSENED AND TRIED AGAIN SAME RESULTS, SURGEON USED BONE NIBBLER TO TURN KNOB, BUT KNOB SHEERED OF THE INSERTED LEAVING CAGE STILL ATTACHED. ADVISED TO REMOVE CAGE AND USE SECOND INTRODUCTION HANDLE WITH ANOTHER CAGE, WHICH HAD GOOD RESULTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22826572 ↗
  • MalfunctionMar 12, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE CAGE INSERTER BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

    Patient problems: Insufficient Information

    MAUDE report 21586997 ↗
  • MalfunctionFeb 7, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

    IT WAS REPORTED THAT THE INNER PART OF THE CAGE INSERTER BROKE OFF WHEN THE CAGE WAS HAMMERED IN. THE CAGE COULD NO LONGER BE SEPARATED FROM THE INSERTER AS THE UPPER PART OF THE CAGE HOLDER NO LONGER HAD ANY HOLD, NO EJECTOR COULD BE USED. THE CAGE COULD BE REMOVED FROM THE DISC SPACE BY THE SURGEON PULLING VERY HARD ON THE CAGE INSERTER. THE CAGE COULD NOT BE SEPARATED FROM THE INSERTER EVEN OUTSIDE OF THE SITUS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

    Patient problems: Insufficient Information

    MAUDE report 21337790 ↗
  • MalfunctionMay 21, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT ON (B)(6) 2024, THE DOCTOR USED THE T-HANDLE INSERTER TO PLACE A SPACER IN THE DISC SPACE. IT WAS A SMALLER SPACER SO THE T-HANDLE DID NOT NEED TO BE TWISTED TO POSITION THE SPACER. WHEN THE SPACER WAS PROPERLY POSITIONED, THE ONE ARM OF THE T-HANDLE FELL OFF AS DOCTOR WAS HANDING THE INSTRUMENT TO THE SURGICAL TECHNOLOGIST. ALL PARTS WERE RETRIEVED AND SAVED AND THE CASE WAS NOT DELAYED. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19366645 ↗
  • MalfunctionApr 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2024, DURING INITIAL SURGERY SETUP, THE CONDUIT STRAIGHT IMPLANT HOLDER AND INNER THREADED DRIVER BECAME WELDED TOGETHER. SURGERY PROGRESSED WITHOUT THOSE INSTRUMENTS. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19098758 ↗
  • MalfunctionSep 20, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE T-HANDLE INSERTER WAS FOUND TO BE BROKEN UPON OPENING THE KIT DURING SURGERY. THE SURGEON MANAGED TO USE THE INSTRUMENT, AND THERE WAS NO IMPACT TO THE PATIENT, AND THERE WAS NO DELAY IN SURGERY. THIS REPORT INVOLVES ONE T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17782286 ↗
  • MalfunctionAug 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON JANUARY 1, 2023, THE T-HANDLE INSERTER TOP BECAME DISCONNECTED. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17560447 ↗
  • MalfunctionJun 15, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023 DURING SPINAL PROCEDURE BOTH POSTERIOR LUMBAR INTERBODY FUSION (PLIF) INSERTERS HAD INTERNAL THREAD DAMAGED AND THE ASSEMBLY WAS DONE WITH DIFFICULTY. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17132613 ↗
  • MalfunctionApr 17, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHILE TIGHTENING THE CAGE INTO THE INSERTER, THE INTERNAL SHIFT BROKE AND THE SURGEON COULD NOT REMOVE THE CAGE. THE INSERTER WAS NOT INSIDE THE PATIENT DURING THIS TIME. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN(15) MINUTES SURGICAL DELAY. SURGEON USED ANOTHER INSERTER TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED AND NO MEDICAL INTERVENTION. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16753947 ↗
  • MalfunctionFeb 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING IMPLANTATION OF CAGE, THE INNER SHAFT SEPARATED FROM THE T HANDLE INSERTER AND WOULDN¿T COME OFF THE CAGE WHILE IN THE PATIENT. THERE WAS 5 MINS OF SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER THIS IS REPORT 1 OF 3 FOR COMPLAINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16342582 ↗
  • MalfunctionJan 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 , AFTER USING THE INSERTER IN QUESTION TO INSERT THE PLIF CAGE, THE INSERTER DID NOT DETACH FROM THE CAGE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15 MINUTES, BUT WAS COMPLETED SUCCESSFULLY AFTER REPLACING BOTH THE CAGE AND INSERTER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16147312 ↗
  • MalfunctionDec 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT ON DECEMBER 7, 2022, DURING IMPLANTATION OF A CONDUIT STRAIGHT T/PLUF CAGE, THE INNER DRIVER OF THE IMPLANT HOLDER WAS FOUND TO BE DISCONNECTED FROM ITS HANDLE. THIS LOCKED THE IMPLANT TO THE DRIVER, AND PREVENTED THE IMPLANT FROM BEING DETACHED AFTER IMPLANTATION. THE SURGEON HAD TO EXPLANT AND WASTE THE CAGE. ANOTHER CAGE OF THE SAME SIZE WAS OPENED, AND A DIFFERENT IMPLANT INSERTER WAS USED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY OF 2 MINUTES. THE IMPLANT AND IMPLANT HOLDER WERE REMOVED, AND A NEW IMPLANT WAS OPENED AND INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE INSERTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16077430 ↗
  • MalfunctionDec 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON UNKNOWN DATE, POST CASE, UPON REASSEMBLY, THE T HANDLE INSERTER INNER THREAD WOULD NOT PROPERLY THREAD INTO THE T HANDLE. IT GOT STUCK UPON REINSERTION. THE PATIENT DID NOT EXPERIENCE A POST OP DEVICE MALFUNCTION OR ADVERSE EVENT. THE PATIENT DOES NOT REQUIRE ANY REMOVAL SURGERY. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15999740 ↗
  • InjuryOct 4, 2022

    THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Foreign Body In Patient

    MAUDE report 15535993 ↗
  • MalfunctionJul 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, ONE CONDUIT EIT PLIF T-HANDLE INSERTER HAD ONE OF THE SIDE HANDLES FALL OFF WHILE INSERTING CAGE. THERE WAS NO SURGICAL DELAY, SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN UNK - CAGE/SPACER: CONDUIT EIT - TLIF. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14986606 ↗
  • MalfunctionJun 16, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE OPERATION THE CONDUIT PLIF INSERTER WAS BROKE. THIS REPORT INVOLVES ONE (1) T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14714489 ↗
  • MalfunctionMay 26, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6), 2022, THE CONDUIT STRAIGHT INSERTER BROKE IN SURGERY. THE SURGEON INSERTED THE CAGE INTO THE DISC SPACE AND VERIFIED WITH C ARM THAT IT WAS IN PLACE. THE SURGEON TRIED TO UNTHREAD THE INSERTER FROM THE CAGE AND IT WOULD NOT RELEASE THE CAGE. THE SURGEON EXTRACTED THE CAGE AND INSERTER FROM THE DISC SPACE. THE KNOB CAME LOOSE FROM THE INSERTER AND FELL ONTO THE FLOOR. THE CAGE WHICH WAS LOADED WITH VIVIGEN WOULD NOT RELEASE FROM THE INSERTER. THE THREADED SHAFT WAS HOLDING THE CAGE ON. IT APPEARS THAT THE WELD BROKE. IT WAS COMPACTED INTO THE ENTIRE CAGE. THE SURGEON USED ANOTHER INSERTER IN THE SET. THERE WAS NO PATIENT CONSEQUENCE AND SURGERY WAS DELAYED BY ABOUT 3 MINS. THIS REPORT INVOLVES ONE (1) T-HANDLE INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14518308 ↗
  • MalfunctionApr 29, 2022Break; Break

    THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO INSERTER DEVICES BROKE. ACCORDING TO THE REPORT, THE SURGEON WAS MALLETING THE BACK OF THE INSERTERS VERY AGGRESSIVELY, CAUSING THE INNER RETAINING SHAFTS TO FRACTURE JUST DISTAL TO THE THREADS THAT ENGAGE THE INSERTER CANNULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE T-HANDLE INSERTER DEVICE. THIS COMPLAINT INVOLVES TWO DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14251212 ↗
  • MalfunctionApr 29, 2022Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO INSERTER DEVICES BROKE. ACCORDING TO THE REPORT, THE SURGEON WAS MALLETING THE BACK OF THE INSERTERS VERY AGGRESSIVELY, CAUSING THE INNER RETAINING SHAFTS TO FRACTURE JUST DISTAL TO THE THREADS THAT ENGAGE THE INSERTER CANNULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14251211 ↗
  • MalfunctionMar 23, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FIXATION SURGERY FOR SPONDYLODESE. DURING SURGERY PART OF THE INSERTER BROKE OFF. NO PATIENT CONSEQUENCES THIS COMPLAINT INVOLVES ONE (1) DEVICE T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13870143 ↗
  • MalfunctionMar 2, 2022Break; Break

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FIXATION OC FUSION SURGERY PART OF THE INSERTER BROKE OFF. FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR A T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13652570 ↗
  • MalfunctionNov 3, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, INTRAOPERATIVELY THE INSTRUMENT FRACTURED AT THE WELDING SEAM WHEN INSERTING THE CAGE. NO FRAGMENT REMAINED IN THE PATIENT. A SECOND INSTRUMENT WAS USED FOR THE FINAL INSERTION OF THE CAGE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM. THIS REPORT IS FOR (1) T-HANDLE INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12749336 ↗
  • MalfunctionAug 19, 2021Break; Break

    IT WAS REPORTED THAT, ON (B)(6) 2021 ON TWO SEPARATE OCCASIONS THE SURGEON WENT TO INSERT A STRAIGHT CONDUIT TLIF CAGE, INSERTED THE CAGE AND ROTATED THE CAGE TO HEIGHT. IT WENT TO RELEASE THE INSERTER FROM THE CAGE AND THE CAGE WOULD NOT RELEASE. INNER SHAFT WOULD CONTINUOUSLY SPIN AND NOT RELEASE. THEN THE INNER SHAFT OF INSERTER BROKE AND CAGE WAS STILL ATTACHED TO BROKEN INSERTER. CAGE AND INSERTER WAS REMOVED AND ANOTHER CAGE WAS OPENED AND ANOTHER INSERTER WAS USED. THIS HAPPENED FOR TWO SEPARATE CAGES AND INSERTERS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATES AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12343757 ↗
  • MalfunctionAug 18, 2021Break; Break

    IT WAS REPORTED THAT, ON (B)(6) 2021 ON TWO SEPARATE OCCASIONS THE SURGEON WENT TO INSERT A STRAIGHT CONDUIT TLIF CAGE AND ROTATED THE CAGE TO HEIGHT. SURGEON TRIED TO RELEASE THE INSERTER FROM THE CAGE AND IT WOULD NOT RELEASE. INNER SHAFT WOULD CONTINUOUSLY SPIN AND NOT RELEASE. THEN THE INNER SHAFT OF INSERTER WAS BROKE AND CAGE WAS STILL ATTACHED TO BROKEN INSERTER. CAGE AND INSERTER WAS REMOVED AND A NEW PAIR OF CAGE AND INSERTER WERE USED. THIS HAPPENED FOR TWO SEPARATE CAGES AND INSERTERS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12339720 ↗
  • MalfunctionAug 12, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT BROKE AT THE WELDING SEAM INTRAOPERATIVELY. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY AND WITH ANOTHER AVAILABLE INSTRUMENT. NO ADVERSE PATIENT HARM. THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12313004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

  • Z-1324-2022 · May 20, 2022 · Open, Classified
    EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
  • Z-1323-2022 · May 20, 2022 · Open, Classified
    EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD

Other Intervertebral Fusion Device With Bone Graft, Lumbar devices

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Sources and updates

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