EIT PLIF Inserter PET30100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260397080832), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A SPINAL FIXATION SURGERY, THE INNER SHAFT ON THE INSERTION TRAIL CAGE BROKE. THERE WAS A SLIGHT DELAY IN SURGERY AND NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) INSERTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9904518 ↗

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