EIT PLIF Handle PET00920Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260397080863), received between Mar 28, 2019 and Jan 6, 2023 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STRAIGHT HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112639 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  COMPLAINANT STATED THAT AN INSTRUMENT WAS JAMMED IN THE INSTRUMENT PET00920 AFTER IMPLANT INSERTION. THE COMPLAINANT POINTED OUT THAT THE EXTRA EFFORT TO DISCONNECT THE INSTRUMENT FROM PET00920 LED TO A SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 8460412 ↗

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