EIT PLIF cage PUI41006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260557778517), received between Jul 28, 2022 and Oct 6, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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

• InjuryOct 6, 2023Migration; Migration

  THE DATE OF THE REVISION WAS (B)(6) 2023. THE ORIGINAL SURGERY WAS (B)(6) 2023. THE SCREWS WERE FINE AND NOT REVISED. PATIENT IS DOING BETTER. THE HOSPITALS LEGAL TEAM WILL NOT RELEASE THE IMPLANT YET DUE TO THE WIFE OF THE PATIENT WAS WANTING TO IMPLANT AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 17887075 ↗
• InjuryJul 28, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A TLIF SPINAL PROCEDURE (DATE UNKNOWN) AND SOME POINT AFTERWARD THE TLIF SPACER EXTRUDED POSTERIORLY INTO THE SPINAL CANAL. PATIENT RETURNED TO THE SURGEON COMPLAINING OF LEFT LEG PAIN. UPON X-RAY, THE MAL-POSITIONED SPACER WAS DISCOVERED AND A REVISION SURGERY WAS SCHEDULED. ON (B)(6) 2022 PATIENT UNDERWENT AN ALIF PROCEDURE TO REMOVE THE TLIF SPACER AND REPLACE WITH A SYNFIX ALIF STAND-ALONE SPACER. THIS REPORT IS FOR ONE (1) POST IBF UI H 10 MM 4DEG 26/9. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 15121201 ↗