EIT PLIF cage PUI81006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260557779972), received between Jul 9, 2020 and Nov 7, 2021 — classified as 1 injury, 1 malfunction.

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

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.

• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SPINAL FUSION SURGERY. DURING THE SURGERY, THE SURGEON WAS DOING A TLIF AT L5-S1 WITH SEVERE DEGENERATIVE DISEASE AND PREVIOUS DECOMPRESSION OF L2-S1. ALSO USED CONDUIT T/PLIF INTERBODY SYSTEM FOR IMPLANT. SURGEON USED PADDLE DISTRACTORS. THE CAGE LOOKED DIFFERENT, MAYBE LONGER. AFTER TAMPING, IT WAS NOTICED THAT SOMETHING LOOKED WRONG WITH IMAGE AND CAGE. ATTEMPTED TO REMOVE THE CAGE BUT ONLY HALF OF THE CAGE CAME OUT BECAUSE IT HAD SHEARED IN HALF. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: T-HANDLE INSERTER (PART# PET30101A, LOT# E20DI0683, QUANTITY 1) UNKNOWN MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN DISTRACTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) POST IBF UI H 10MM 8DEG 26/9. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760840 ↗
• InjuryJul 9, 2020Migration; Migration

  IT WAS REPORTED ON AN UNKNOWN DATE THAT ON (B)(6) 2020, THE SURGEON PERFORMED AN EXTENSION OF A BILATERAL PEDICLE SCREW CONSTRUCT FROM L2-4 WHERE HE EXTENDED THE CONSTRUCT DOWN TO L5 AND INSERTED A CONDUIT STRAIGHT TLIF CAGE AT THE L4/5 DISC SPACE. THIS CASE WAS DONE BECAUSE OF A GRADE 1/GRADE 2 SPONDYLOLISTHESIS. ON (B)(6) THE SURGEON INFORMED THAT HE NEEDED TO REMOVE THE CAGE BECAUSE OF NONUNION AND HAD MIGRATED POSTERIOR TOWARDS THE SPINAL CANAL. THE SURGEON PERFORMED THE SURGERY AND WAS ABLE TO REMOVE THE CAGE WITHOUT ANY ISSUES. HE THEN USED ANOTHER COMPANY TO INSERT A LATERAL CAGE. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) POST IBF UI H 10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10254956 ↗