EIT PLIF InserterRecalls & reported problems across all models

We found 3 models of EIT PLIF Inserter by EIT Emerging Implant Technologies GmbH in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2019 and Aug 18, 2025 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Break” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EIT PLIF Inserter problems

EIT PLIF Inserter models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EIT PLIF Inserter PET30101

  Intervertebral Fusion Device With Bone Graft, Lumbar
  31 reports
• EIT PLIF Inserter PET30102

  Intervertebral Fusion Device With Bone Graft, Lumbar
  8 reports
• EIT PLIF Inserter PET30100

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report

Recent EIT PLIF Inserter adverse event reports

The 15 most recent reports across all models, 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) INSERTER SH CONNECTION THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099563 ↗
• 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 ↗
• MalfunctionMar 29, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 12-MARCH-2024, THE SURGEON HAD TROUBLE DETACHING THE INSERTER IN QUESTION FROM THE IMPLANT ONCE IT WAS POSITIONED IN SITU. EXCESSIVE FORCE WAS REQUIRED FOR THE DISENGAGEMENT OF THE IMPLANT HOLDER. THIS PROCESS CAUSED THE SPINDLE TIP TO FRACTURE, LEAVING IT EMBEDDED WITHIN THE IMPLANT. THE FRACTURE WAS FLUSH WITH THE IMPLANT AND COULD NOT BE REMOVED. THE BROKEN FRAGMENT WAS LEFT WITHIN THE IMPLANT INSIDE OF THE PATIENT BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. THE GENERATED FRAGMENT WAS LEFT INSIDE OF THE IMPLANT, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN INSERTER S-HAMMER CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003223 ↗
• 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 ↗
• MalfunctionSep 14, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE ITEM PET30102 WITH LOT NUMBER E19DI0693 CONSISTS OF TWO PARTS BUT CANNOT BE PUT TOGETHER BECAUSE THE SCREW THREAD IS DEFECTIVE. THIS REPORT IS FOR ONE (1) INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743639 ↗
• 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) INSERTER SH CONNECTION THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132616 ↗
• 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 15, 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) INSERTER S-HAMMER CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382974 ↗
• 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 DEVICES. THIS REPORT IS FOR ONE INSERTER SH CONNECTION. THIS IS REPORT 2 OF 3 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342868 ↗

Other EIT Emerging Implant Technologies GmbH products

• EIT TLIF Inserter4 models · 140 reports
• EIT CIF cage6 models · 14 reports · 2 recalls
• EIT LLIF Inserter2 models · 60 reports
• EIT PLIF Hammer2 models · 32 reports
• EIT ALIF Inserter3 models · 25 reports