ShurFit Interbody Device TLIF30-08PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019909907), received between Jan 4, 2021 and Jan 12, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJan 12, 2021Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A 2 LEVEL REFORM TI AND SHURFIT TLIF CASE (L2 - L4) PERFORMED ON (B)(6) 2020. PER THE SURGEONS TECHNIQUE, HE PLACED THE REFORM TI SCREWS IN FIRST, DISTRACTED THE L2-3 DISC SPACE WITH A LAMINA SPREADER, CLEARED THE DISC WITH GENERAL SURGICAL INSTRUMENTS (KERRISONS, PITUITARIES, SHAVERS), AND THEN INSERTED THE 6MM SHURFIT TLIF TRIAL AND THEN THE 8MM SHURFIT TLIF TRIAL WITHOUT ANY ISSUES. BASED ON THE 8MM TRIAL SIZING, HE THEN INSERTED THE TLIF30-08P WITH THE SHURFIT INSERTER. UPON MALLETING THE BACK END OF THE INSERTER TO PLACE THE CAGE INTO THE DISC SPACE, THE TLIF CAGE BROKE IN-SITU. THE BROKEN PIECE WAS NOT IN THE DISC SPACE AND WAS ABLE TO BE REMOVED AND THE PROCEDURE COMPLETED UTILIZING A COMPETITOR'S INTERBODY IMPLANT WITHOUT ANY FURTHER ISSUES. THERE WAS A TEN (10) MINUTE DELAY TO THE PROCEDURE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11155204 ↗
• InjuryJan 4, 2021Break

  A 3-LEVEL MIS POSTERIOR FIXATION PLUS FUSION PROCEDURE WAS PERFORMED ON (B)(6) 2020 IN (B)(6), UTILIZING THE SURE-LOK MIS 3L SYSTEM. WHEN THE SURGEON WAS "PUNCHING" ON THE CAGE TO LOCATE IT IN ITS POSITION, THE TLIF CAGE PEEK 8MM X 30MM (TLIF30-08P) BROKE INSIDE THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE BROKEN CAGE AND ANOTHER WAS INSERTED SUCCESSFULLY. AFTER PLACING CAGES AND BEGINNING TO FIX THE SCREWS, WHILE PLACING THE SECOND ROD, THE SURGEON WAS INSERTING THE LOCK-SCREW, A STRANGE SOUND WAS HEARD, AND IT WAS FOUND THAT THE TIP OF THE CL ROD INSERTER (63-CL-9005) WAS BROKEN OFF. THE BROKEN PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE ROD WAS ALREADY IN PLACE. THERE WAS NO PATIENT HARM REPORTED, BUT THERE WAS A ONE (1) HOUR DELAY TO THE PROCEDURE AS A RESULT OF THESE MALFUNCTIONS.

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

  MAUDE report 11108462 ↗