EIT PLIF Shaver PFT10900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260397082690), received between Sep 26, 2022 and Sep 26, 2022 — classified as 1 death.

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 16, 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.

• DeathSep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN L4-L5 SPONDYLOLISTHESIS PROCEDURE, THE SURGEON INJURED THE AORTA DURING INSERTION AND DURING USE OF THE 9 MM SHAVER IN THE DISC SPACE. EMERGENCY LAPAROTOMY BY VASCULAR SURGERY WAS PERFORMED TO MANAGE THE BLEEDING. THE PATIENT DIED ABOUT 45 MINUTES LATER DUE TO BLOOD LOSS. THIS REPORT INVOLVES ONE SHAVER, H 9 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15487067 ↗

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