EIT ALIF Inserter AET30101Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04260557774786), received between Jun 25, 2020 and Mar 29, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CASE, THE SPINE SURGEON WAS TRYING TO DISTRACT THE DISC SPACE FOR ALIF CASE. THE DISTRACTOR THREAD AT THE DISTAL END OF THE INSTRUMENT WAS DAMAGED (LOOKED BENT) SO IT WOULD NOT THREAD/LOCK PROPERLY FOR DISTRACTION. THEY MANAGED THIS BY HAVING THE ACCESS SURGEON TO HOLD AND TIGHTEN THE DISTRACTOR MANUALLY WITHOUT THREADING THE LOCKING MECHANISM. DURING THIS SAME CASE, WHEN THE SURGEON WAS INSERTING THE CAGE WITH THE CAGE INSERTER. THE CAGE WAS MALLETED IN AS PER USUAL PROCESS. WHEN THE SURGEON WENT TO UNDO THE INSERTER FROM THE CAGE TO DISENGAGE. THE INSERTER SPINDLE AT THE DISTAL END WOULD NOT TURN. AFTER MULTIPLE ATTEMPTS, THE SURGEON REMOVED THE CAGE ALTOGETHER WITH THE INSERTER. WE HAD ANOTHER INSERTER IN THE SET AS WELL AS ANOTHER SAME SIZE IMPLANT. CASE WAS COMPLETED WITH 5 MINUTES DELAY WITH NO ADVERSE TO PATIENT REPORTED. THIS REPORT INVOLVES ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004634 ↗
• MalfunctionJul 27, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AND A GOOD OUTCOME WAS ACHIEVED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405443 ↗
• MalfunctionJun 5, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DEMONSTRATION WAS DONE WITH THE CONDUIT LLIF, AND THE IMPLANT INTRODUCED GOT JAMMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059207 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES 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 SH CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852462 ↗
• MalfunctionFeb 9, 2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335322 ↗
• MalfunctionSep 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT AFTER POSITIONING THE CAGE IN THE INTERVERTEBRAL DISC SPACE, THE INSERTION COULD NOT BE DETACHED FROM THE CAGE. THIS CAUSED A SURGICAL DELAY OF 60 MINUTES. THIS REPORT INVOLVES ONE IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395749 ↗
• InjuryAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AFTER THE ALIF CAGE WAS PLACED IN THE L5/S1 SEGMENT (ACCESS ANTEROLATERAL FROM THE LEFT), SURGEON REMOVED THE IMPLANT HOLDER FROM THE CAGE. AFTER CONTROL, THE CONDUIT ALIF NEEDED TO BE REPOSITIONED, BECAUSE THE POSITION WAS NOT SATISFACTORY AS PER X-RAY. AGAIN, SURGEON CONNECTED IMPLANT HOLDER TO THE CAGE FOR REPOSITIONING OF THE CAGE. AFTER THIS PROCEDURE THE IMPLANT HOLDER WAS NOT POSSIBLE TO BE REMOVED FROM THE CAGE. IT WAS NO LONGER POSSIBLE TO TURN THE KNOB TO THE RIGHT OR LEFT SIDE (OPEN /CLOSED). SURGEON REMOVED THE CAGE HOLDER AND CONNECTED CAGE FROM THE DISC SPACE L5/S1 AND DID ALTERNATIVE IMPLANTATION OF A TM400 COMPETITOR CAGE. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 15153395 ↗
• MalfunctionJul 19, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE IMPLANT INSERTER IN QUESTION GOT STUCK ON THE CAGE BEING IMPLANTED AND WOULD NOT COME APART. THE CAGE WAS ABLE TO BE REMOVED FROM THE INSERTER, BUT THE END OF THE DEVICE WAS CROSS-THREADED. IT WAS ULTIMATELY DECIDED THAT THE CAGE SHOULD NOT BE IMPLANTED. THERE IS NO REPORTED ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058272 ↗
• MalfunctionJul 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON COULD NOT DETACH THE CAGE FROM THE INSERTER. THE CAGE WAS ALREADY CORRECTLY POSITIONED IN THE LIGAMENT SHEATH SPACE, SO THE SURGEON HAD TO COMPLETELY REMOVE THE CAGE WITH INSERTION AND USE ANOTHER SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 40 MINUTE DELAY. THIS REPORT IS FOR AN IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14932612 ↗
• MalfunctionJan 31, 2022Device-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, AFTER INSERTING THE IMPLANT, THE SURGEON COULD NOT DETACH THE INSERTER FROM THE IMPLANT. IT HAD TO BE COMPLETELY REMOVED AGAIN AND CANCELED. THERE WAS A TWENTY FIVE (25) MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391894 ↗
• MalfunctionDec 21, 2021Material Deformation; Material Deformation

  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, WHEN INSERTING AN IMPLANT, THE INSTRUMENT WAS BENT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED. ALIF UI H 12MM 10DEG S (PART# AUI31234, LOT# UNKNOWN, QTY1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) IMPLANT INSERTER SH CONNECTION THIS REPORT IS 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053769 ↗
• MalfunctionNov 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AFTER IMPLANTATION OF THE CAGE, THE PLACEMENT INSTRUMENT ((B)(4)) COULD NO LONGER BE DETACHED FROM THE IMPLANT ((B)(4)). THE IMPLANT HAD TO BE REMOVED AND A NEW ONE WHICH WAS INSERTED WITH AN ALTERNATIVE PLACEMENT INSTRUMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN(15) MINUTES DELAY. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745574 ↗
• MalfunctionAug 24, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  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 WANTED TO REMOVE THE IMPLANT INSERTER FROM THE IMPLANT, THE KNOB AT THE BACK OF THE BLACK HANDLE COULD NOT BE TURNED AND GOT STUCK. THE IMPLANT COULD NOT BE RELEASED FROM THE IMPLANT INSERTER AND HAD TO BE REMOVED FROM THE PATIENT. AT A SECOND TRY TO RELEASE THE IMPLANT, OUTSIDE OF THE PATIENT ON A SIDE TABLE, THE INNER SHAFT OF THE IMPLANT INSERTER BROKE OFF AND A SHORT PIECE OF THE INNER SHAFT STAYED STUCK WITHIN THE METAL KNOB. THE IMPLANT WAS RELEASED FROM THE HOLDER AND HAD THEN TO BE IMPLANTED FREEHAND, BECAUSE THERE WAS NO SECOND IMPLANT INSERTER OR ANY OTHER ALTERNATIVE ON THE SET. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362319 ↗
• MalfunctionAug 16, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 WHILE IMPACTING, THE INSTRUMENT BENT. ANOTHER CONSIGNED INSTRUMENT IN HOSPITAL WAS USED. THERE WAS NO PATIENT IMPACT OR DELAY TO SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328400 ↗
• MalfunctionAug 16, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 WHILE IMPACTING, THE INSTRUMENT BENT. ANOTHER CONSIGNED INSTRUMENT IN HOSPITAL WAS USED. THERE WAS NO PATIENT IMPACT OR DELAY TO SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328397 ↗
• MalfunctionAug 16, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 WHILE IMPACTING, THE INSTRUMENT BENT. ANOTHER CONSIGNED INSTRUMENT IN HOSPITAL WAS USED. THERE WAS NO PATIENT IMPACT OR DELAY TO SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328378 ↗
• MalfunctionAug 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE INSERTER WOULD USUALLY CATCH THEN YOU TURN THE END TO TIGHTEN THE IMPLANT ON HOWEVER THIS WOULD NOT WORK. THE ISSUE WAS RESOLVED WITH HOSPITAL SET. THERE WAS NO DELAY TO SURGERY OR PATIENT IMPACT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328298 ↗
• MalfunctionAug 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE INSERTER WOULD USUALLY CATCH THEN YOU TURN THE END TO TIGHTEN THE IMPLANT ON HOWEVER THIS WOULD NOT WORK. THE ISSUE WAS RESOLVED WITH HOSPITAL SET. THERE WAS NO DELAY TO SURGERY OR PATIENT IMPACT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER SH CONNECTION. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328243 ↗
• MalfunctionJun 25, 2020Material Twisted/Bent; Material Twisted/Bent

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THE PART IS A SUB-COMPONENT OF ANOTHER REPORTED DEVICE AND IS ALREADY CAPTURED ON REPORT 1526439-2020-01266.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10196513 ↗

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-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
• 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