EIT CIF Inserter CET30131Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260397082829), received between Jul 18, 2019 and Feb 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  DURING SET UP IN THE PREP ROOM, THE T-PIECE (PART C) THREAD IS DAMAGED AND NOT HOLDING THE PART TOGETHER. SLIM INSERTER MAD UP OF 5 PARTS CAME DISASSEMBLED IN TRAY, WHEN PUT TOGETHER IN THE PRE ROOM THE T PIECE OF PART C CAME OFF THE THREAD AND WAS THEN SLIPPING OFF DUE TO DAMAGED THREAD SO ITEM WAS UNUSABLE AND IN NEED OF REPLACEMENT. ITEM WAS RETURNED TO SDU FOR CLEANING AND PACKING SEPARATELY FOR POTENTIAL RETURN. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322404 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A 3 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY, THE SURGEON SUCCESSFULLY INSERTED A CONDUIT ACIF CAGE ON THE SECOND LEVEL USING THE SLENDER INSERTER. WHEN THE INSERTER WAS HANDED BACK TO THE SCRUB, THE DEPTH STOP COMPONENT OF THE INSERTER BROKE OFF, AND IT APPEARS THAT THE THREADED PORTION HOLDING IT ONTO THE INSTRUMENT WAS BROKEN AND THEREFORE COULD NOT BE FIXED. NO FRAGMENTS WERE GENERATED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE BECAUSE THERE ARE 2 TYPES OF INSERTERS IN THE SET. THEREFORE, THE SURGEON USED THE OTHER AVAILABLE INSERTER FOR THE FINAL CAGE INSERTION. THERE WAS NO PATIENT CONSEQUENCE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) SLENDER INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146649 ↗
• MalfunctionAug 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE EIT SLIM/SLENDER INSERTER BROKE. THE STOPPER PIECE ENDED UP SHEARING OFF AS THEY WERE INSERTING ONE (1) OF THE SPACERS. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8909824 ↗
• MalfunctionJul 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ARRIVAL AT THE SHIPPING PICKUP LOCATION, GARY OPENED THE SET TO DISCOVER THE DAMAGE TO THE SLENDER INSERTER AND UPON INSPECTION IT WAS NOTICED THAT THERE IS ALSO DISCOLORATION ON THE IMPACTOR. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8804395 ↗

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