EIT ALIF Inserter AET20101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260557774779), received between Jan 17, 2020 and Sep 13, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Device-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) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736734 ↗
• MalfunctionFeb 9, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023 , THAT DURING TRAIL IMPLANT INSERTION THE TRIAL INSERTER INSTRUMENT X 1 REF AET20101 BENT/DEFORMED AND DURING IMPLANT INSERTION THE IMPLANT INSERTER INSTRUMENT REF AET30101 X1. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. THIS REPORT IS FOR ONE (1) TRIAL INSERTER SH CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335349 ↗
• MalfunctionJun 25, 2020Material Twisted/Bent; Material Twisted/Bent

  UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN CONDUIT CAGE ALIF (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN), UNKNOWN IMPLANT INSERTER CONNECTION EIT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN), IMPLANT INSERTER (PART#: AET30100, LOT#: E16DI0200, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10196527 ↗
• InjuryJan 17, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SPINAL FIXATION SURGERY ON (B)(6) 2019, THE INSERTER WAS USED TO INSERT THE CONDUIT TLIF IMPLANT. UPON TAPPING THE INSERTER WITH A HAMMER, ACCORDING TO THE SURGICAL TECHNIQUE, THE IMPLANT STARTED TO TURN TOO SOON. THE FIXATION KNOB WAS TIGHTENED AS MUCH AS POSSIBLE, YET STILL THE IMPLANT STARTED TO HINGE ON THE HOLDER (AS IT WAS DESIGNED TO DO, BUT ONLY AFTER LOOSENING OF THE FIXATION KNOB, WHICH WAS NOT YET DONE IN THIS CASE). THERE MIGHT HAVE BEEN TISSUE DAMAGE CAUSED, BUT THIS WAS NOT CONFIRMED AS NO REPORT WAS MADE TO THE DPS/JNJ REP. A TAMP WAS USED TO INSERT THE IMPLANT TO ITS CORRECT POSITION. THE INSERTION INSTRUMENT WAS HANDED OVER TO DPS/JNJ REP WITH A BROKEN INNER SHAFT, YET NO REPORT WAS MADE TO US THIS BREAKAGE OCCURRED INTRAOPERATIVELY. THE INNER SHAFT OF THE INSERTER BROKE AT THE DESIGNED POINT HIGH INSIDE THE OUTER SHAFT. NO FURTHER INFORMATION WAS PROVIDED. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE ON JANUARY 17, 2020 IT WAS IDENTIFIED THAT THE TIP OF THE RETURNED DEVICE WAS DEFORMED. CONCOMITANT DEVICE: IMPLANT INSERTER SH CONNECTION (PRODUCT

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9603708 ↗

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