EIT LLIF Inserter LET30100Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04260557837733), received between Nov 23, 2021 and Aug 6, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THE CONDUIT LLIF INSERTER BROKE INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED AS DOING REALLY WELL. THIS REPORT IS FOR A CONDUIT LLIF INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917880 ↗
• MalfunctionAug 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE HAS BEEN NO REMOVAL/ REVISION SURGERY AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 19882822 ↗
• MalfunctionFeb 15, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON AN ATP PROCEDURE WITH LLIF CONDUIT DURING THE INSERTION OF THE CAGE THE ANTI-ROTATION PART OF INNER SHAFT OF THE INSERTER WAS BROKEN. DURING THE IMPLANTATION OF THE CAGE THIS METAL PART OF THE INSTRUMENT DISAPPEARED BETWEEN THE ENDPLATE AND THE CAGE INTO THE DISC SPACE L3-4. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18711219 ↗
• MalfunctionDec 4, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)-2023 THE PATIENT WAS UNDERGOING A LLIF PROCEDURE. DURING INSERTION OF THE IMPLANT AFTER HAMMERING IT INTO THE RIGHT POSITION, THE KNOB OF THE INSERTER GOT STUCK. THE KNOB WOULDN¿T ROTATE IN EITHER DIRECTION, MAKING IT IMPOSSIBLE TO DETACH IT FROM THE IMPLANT. WHEN THE SURGEON APPLIED FORCE ON THE KNOB, THE INNER SHAFT BROKE. THE SURGEON DECIDED TO KEEP THE IMPLANT IN THE PATIENT, BUT NO FURTHER IMPLANT INSERTERS WERE AVAILABLE, SO THE CAGE WAS NOT OPTIMALLY PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257514 ↗
• MalfunctionDec 4, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT WAS UNDERGOING A LLIF PROCEDURE. DURING INSERTION OF THE IMPLANT AFTER HAMMERING IT INTO THE RIGHT POSITION, THE KNOB OF THE INSERTER GOT STUCK. THE KNOB WOULDN¿T ROTATE IN EITHER DIRECTION, MAKING IT IMPOSSIBLE TO DETACH IT FROM THE IMPLANT. WHEN THE SURGEON APPLIED FORCE ON THE KNOB, THE INNER SHAFT BROKE. THE SURGEON DECIDED TO KEEP THE IMPLANT IN THE PATIENT, BUT NO FURTHER IMPLANT INSERTERS WERE AVAILABLE, SO THE CAGE WAS NOT OPTIMALLY PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257506 ↗
• MalfunctionOct 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, AN INSERTER BECAME JAMMED. THE TEAM WAS ABLE TO DETACH IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN FOURTEEN MINUTES DELAY. THE PATIENT IS DOING WELL. THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961165 ↗
• MalfunctionJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136240 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT A CUSTOMER REPORTED, THE INSTRUMENTS CAN NO LONGER BE MOUNTED AND THUS CAN NO LONGER BE USED FOR SURGICAL PROCEDURES. THIS WAS DETERMINED OUTSIDE OF AN OPERATION, SO NO DAMAGE WAS CAUSED. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852423 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 6, 2023, INTRA OPERATIVELY WE COULD NOT LOOSEN THE IMPLANT INSERTER FROM THE CAGE ITSELF IN SITU. THE CAGE CONNECTED TO THE IMPLANT INSERTER WAS ALREADY IMPLANTED BUT WE COULD NOT DISCONNECT THE INSTRUMENT FROM THE IMPLANT AND HAD TO EXPLANT THE CAGE AGAIN. WE TOOK THE BACK UP INSTRUMENT FROM THE TRAY AND HAD TO OPEN ANOTHER STERILE IMPLANT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593069 ↗
• MalfunctionFeb 15, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THAT INTRAOPERATIVELY IT WAS NO LONGER POSSIBLE TO REMOVE THE CAGE INSERTER FROM THE CONDUIT LLIF CAGE. AFTERWARDS, THE CAGE INCLUDING THE HOLDER WAS REMOVED AND REPLACED BY AN ALTERNATIVE (STROMBOLI-CAGE/FA. ULRICH). NO PATIENT HARM. SURGERY DELAY TIME CA. 20 MIN. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378431 ↗
• MalfunctionFeb 7, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING THE PROCEDURE, THE IMPLANTATION TOOL JAMMED. WHEN THE IMPLANT WAS ALREADY IN THE PATIENT THERE WAS A PROBLEM WITH PULLING THE IMPLANT FROM THE FEEDER. THE DELAY IN THE PROCEDURE WAS LESS THAN 30 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO CONSEQUENCES THIS REPORT IS FOR ONE (1) IMPLANT INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313439 ↗
• MalfunctionDec 23, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT THE CONDUIT LLIF INSERTER BROKE AND WOULDN¿T RELEASE THE IMPLANT. THE IMPLANT HAD TO BE REMOVED AND ANOTHER ONE OPENED AS IT COULDN¿T BE TAKEN OFF THE INSERTER. THERE WAS MINIMAL DELAY AND THE CASE WENT WELL IN THE END WITH THE PATIENT DOING WELL NOW. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042132 ↗
• MalfunctionDec 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022 , DURING IMPLANT INSERTION THE IMPLANT INSERTER HOLDER ROD (INTERNAL) SHEERED/SNAPPED INSIDE THE INSTRUMENT AT THE THREADED END RENDERING THE INSTRUMENT USELESS. FORTUNATELY THE SURGEON WAS ABLE TO SAFELY DETACH THE INSTRUMENT FROM THE IMPLANT WHICH WAS INSIDE THE PATIENT AND FINISH THE OPERATION WITHOUT COMPROMISING THE OUTCOME. ALL PIECES OF THE BROKEN INSTRUMENT WERE REMOVED FROM THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969996 ↗
• MalfunctionNov 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL PROCEDURE ON (B)(6) 2022, THE CONDUIT LLIF IMPLANT HOLDER COULD NOT BE REMOVED FROM IMPLANT. THE PROCEDURE WAS DELAYED FOR AN UNKNOWN AMOUNT OF TIME IN RELATION TO THIS EVENT. THE IMPLANT AND HOLDER WAS REMOVED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797606 ↗
• MalfunctionNov 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL INSERTER DEVICES WERE DEFECTIVE. THE CUSTOMER WAS NOT ABLE TO ASSEMBLE THE INSTRUMENTS, AND THE HAMMER SHOWED A FRACTURE. NO PATIENT WAS HARMED, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TRIAL INSERTER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770017 ↗
• MalfunctionOct 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE CAGE DID NOT MOVE FROM THE INSERTER AFTER IMPLANT PLACEMENT. SURGERY WAS DELAYED BY 30 MINUTES AS A RESULT OF THIS EVENT. THE SURGEON REMOVED THE CAGE WITH THE INSERTER AND USED A CAGE FROM A DIFFERENT COMPANY. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698396 ↗
• MalfunctionAug 1, 2022Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE IMPLANT INSERTER BROKE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140737 ↗
• MalfunctionJul 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6)2022, THE IMPLANT TRAY WAS BLOCKED, AND THE TOOL COULD NOT BE DETACHED FROM THE IMPLANT. THE GAUGE FEEDER WAS STUCK AND THE TOOL COULD NOT BE UNFOLDED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103502 ↗
• MalfunctionJul 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A MINI ALIF PROCEDURE (AS PER MAYER/ L4/5 / ACCESS FROM THE RIGHT, LEFT LATERAL POSITION), AFTER INSERTING THE CONDUIT LLIF CAGE, IT WAS NOT POSSIBLE TO DETACH THE INSERTION INSTRUMENT FROM THE CAGE. THE INSERTION INSTRUMENT BLOCKED THE CAGE AND IT COULD NOT BE RELEASED. THE CAGE WAS REMOVED WITH HELP OF THE IMPLANT-POSITIONING INSTRUMENT. ANOTHER FREESTYLE CAGE WAS INSERTED WITH THE HELP OF AN IMPLANT-PUSHER. THE TRIAL IMPLANT HOLDER ALSO JAMMED DURING DISASSEMBLY AND WAS BLOCKED COMPLETELY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE, SURGERY WAS DELAYED FOR APPROXIMATELY 15 MINUTES. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102765 ↗
• MalfunctionJul 18, 2022Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE THREE SUB-COMPONENTS OF THE IMPLANT INSERTER COULD NOT BE REMOVED FROM ONE ANOTHER. THE INDIVIDUAL PARTS WERE STERILIZED WHILE ASSEMBLED AND CANNOT BE DISASSEMBLED. THERE IS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047751 ↗
• MalfunctionJun 15, 2022Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: DURING AN INSPECTION AT THE LOANER SET DEPARTMENT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE IMPLANT HOLDER IS BROKEN. NO SURGERY IMPACT, NO PATIENT IMPACT. THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14695124 ↗
• MalfunctionMar 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT AN IMPLANT DID NOT COME OFF THE INSERTER DURING THE WORKSHOP. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967728 ↗
• MalfunctionMar 11, 2022Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AFTER PLACING THE IMPLANT IN THE CORRECT POSITION IT WAS NOT POSSIBLE TO REMOVE THE IMPLANT FROM THE INSTRUMENT. THE INSTRUMENT JAMMED. SURGERY COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. NO ADVERSE PATIENT HARM OR IMPACT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THIS REPORT INVOLVES ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739500 ↗
• MalfunctionNov 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE THE INSTRUMENT BECAME BLOCKED AND COULD NOT BE USED TO INSERT THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861030 ↗