T-PLIF 389.274Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034775289), received between May 23, 2022 and Mar 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT STERILIZATION DEPARTMENT HAS NOTIFIED THAT THE TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) INSTRUMENTS WITH A 'WOODEN' HANDLE REQUIRED TO BE CHANGED AS THERE WAS PRESENCE OF RUST AND THE INSTRUMENTS ON CONSIGNMENT ARE VERY OLD. THERE WAS NO PATIENT IMPACT AND NO DELAYS. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THERE WAS FOREIGN SUBSTANCE AT THE END OF THE HANDLE OF T-PLIF IMPACTOR-STRAIGHT. THIS REPORT IS FOR ONE (1) T-PLIF IMPACTOR-STRAIGHT . THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583836 ↗
• MalfunctionMar 14, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT STERILIZATION DISCOVERED THAT ALL TPLIF INSTRUMENTS WITH A 'WOODEN' HANDLE NEEDS TO BE CHANGED AS THERE WAS PRESENCE OF RUST AND THE INSTRUMENTS ON CONSIGNMENT ARE VERY OLD. TWO (2) SETS TO ADDRESS. NO PATIENT WAS IMPACTED AND NO DELAYS WERE OBTAINED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) T-PLIF IMPACTOR-STRAIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536971 ↗
• MalfunctionMar 13, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT STERILIZATION DISCOVERED THAT ALL TPLIF INSTRUMENTS WITH A 'WOODEN' HANDLE NEEDS TO BE CHANGED AS THERE WAS PRESENCE OF RUST AND THE INSTRUMENTS ON CONSIGNMENT ARE VERY OLD. TWO (2) SETS TO ADDRESS. NO PATIENT WAS IMPACTED AND NO DELAYS WERE OBTAINED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) T-PLIF IMPACTOR-STRAIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530632 ↗
• MalfunctionMay 23, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT ON (B)(6) 2022, THE SURGEON WAS DOING A SPINAL CASE USING THE TLIF AND THE SYNMESH SYSTEMS. WHILE DOING SO, USING THE TLIF GRAFT PUSHER THE PROXIMAL END HAD A PLATE OF 'METAL' FOLLOWED BY THE HANDLE. IT WAS REPORTED THAT WHEN THE SURGEON WAS INSERTING THE TLIF CAGE FURTHER, THERE WAS SOME SORT OF POWDER THAT CAME OUT BETWEEN THE METAL PLATE AND THE HANDLE. THE SAME INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14472060 ↗