EIT PLIF Handle PET00910Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260397080856), received between Aug 22, 2022 and Jan 18, 2024 — 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 UPON POST CASE INSPECTION, THE BLACK T-HANDLE IN QUESTION COMPLETELY FELL APART DURING THE WASHING PROCESS. THE SPRING WITHIN THE T-HANDLE FELL OUT. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536894 ↗
• MalfunctionMay 2, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY. UNKNOWN IF SURGERY WAS DELAYED OR PROCEDURE SUCCESSFULLY COMPLETED DUE TO THE REPORTED EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852374 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE TWO SEPARATE T-HANDLES BROKE. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606717 ↗
• MalfunctionAug 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THE SET WAS RECEIVED WITH A CONDUIT T-HANDLE INSTEAD OF A 3.0NM TORQUE-LIMITING HANDLE. THE PROVIDED HANDLE DOESN¿T FIT THE MATRIX X-LINK AND SO THE REMOVAL PROCEDURE COULD NOT BE SCHEDULED. THIS REPORT IS FOR A T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265219 ↗

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