T-PLIF 389.266Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034775210), received between Mar 30, 2017 and Feb 23, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: THE SURGEON WAS INSERTING A TPLIF GRAFT FROM MTF AND ONE OF THE 'ARMS' AT THE PROXIMAL TIP WAS SIGNIFICANTLY BENT. THE NURSE SUBSEQUENTLY ATTEMPTED TO STRAIGHTEN THE ARM AND IT BROKE OFF ON THE BACK TABLE. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE OTHER SET FOUND AT THE HOSPITAL. NOTHING FELL INTO THE PATIENT AND THE PATIENT WAS NOT IMPACTED, THEREFORE NO PATIENT DETAILS WERE OBTAINED. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT INTERVENTIONAL. NO FRAGMENTS FELL INTO THE PATIENT AND THE PIECE WAS THROWN AWAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18770334 ↗
• MalfunctionJan 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON INSERTED A TPLIF HOLDER, DURING THIS PROCESS, THE TPLIF HOLDER AT THE DISTAL END PRONG BENT. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ANY DELAYS OR CONSEQUENCES TO THE PATIENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249682 ↗
• MalfunctionJun 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DR. WAS DOING AN ANTERIOR AND POSTERIOR APPROACH ON THE SAME PATIENT. FOR THE POSTERIOR APPROACH, UPON IMPACTING THE TPLIF CAGE, THERE WAS 'DUST/POWDER' COMING OUT OF THE TPLIF IMPACTOR (WHERE THE METAL END MEETS THE HANDLE). THE SURGEON COMPLETED THE CASE WITH ANOTHER IMPACTOR. AND FOR THE ANTERIOR APPROACH WITH THE SYNFRAME, THE REGION WHERE THE GUIDE ROD HOLDS THE BLADE BROKE (TWO GUIDE RODS BROKE DURING BLADE INSERTION). IN BOTH CASES THE PATIENT WAS NOT IMPACTED AND THERE WAS NO DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678848 ↗
• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION AT STERILE PROCESSING, THE SCREW OF A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) IMPLANT HOLDER FELL OUT OF THE HOLDER. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9455815 ↗
• MalfunctionDec 27, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF A CONSIGNMENT SET ON AN UNKNOWN DATE, THE TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) IMPLANT HOLDER WAS FOUND TO HAVE A BENT TIP. THE DEVICE WAS NOTED TO BE DAMAGED BUT NOT BROKEN. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8199244 ↗
• MalfunctionOct 24, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT POSTERIOR SPINAL FUSION WHEN THE T-PLIF IMPLANT HOLDER BROKE INTRA-OPERATIVELY. IT IS UNKNOWN IF THERE WERE FRAGMENTS FROM THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999754 ↗
• MalfunctionMay 18, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS OF THE T-PLIF IMPLANT HOLDER, A SCREW CAME OFF AND THE DISTAL END TIP ARM CAME OFF ON ONE SIDE ONLY. MALFUNCTION OCCURRED POST-OP. THERE WAS NO PATIENT INVOLVEMENT. DURING THE MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE SLOTTED SCREW WAS MISSING AND ONE OF THE DISTAL TIPS OF THE DEVICE WAS NOTED TO BE BROKEN; NEITHER PIECE WAS RETURNED. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7527658 ↗
• InjuryMar 30, 2017Bent; Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT LEVELS L3-S1 FOR DEGENERATIVE DISC DISEASE. AS THE SURGEON WAS USING THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) CAGE SYSTEM, HE EXPERIENCED SEVERAL ISSUES. THE FIRST ISSUE OCCURRED AS THE SURGEON WAS TRIALING AT L3-4. AFTER HE PUT THE TRIAL SPACER IN AND REMOVED IT, HE NOTICED THAT IT KEPT COMING UNTHREADED AND THEN EVENTUALLY, HE NOTICED THE TIP OF THE TRIAL SPACER HAD BECOME STUCK IN THE APPLICATOR KNOB AND SHEARED OFF. IT WAS REPORTED THAT ONCE THE TRIAL SPACER BROKE, THE SURGEON WAS NOT ABLE TO GET THE APPLICATOR KNOB TO TURN. THE TIP OF THE TRIAL SPACER REMAINS WEDGED IN THE APPLICATOR KNOB. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO GET AN IDEA OF THE HEIGHT OF THE IMPLANT EVEN THOUGH THE TRIAL SPACER WAS BROKEN. THE NEXT ISSUE HAPPENED AS THE SURGEON WAS USING THE INNER SHAFT TO INSERT THE 7MM T-PAL SPACER AND THE TIP OF THE INNER SHAFT BECAME STUCK IN A SECOND APPLICATOR KNOB AND SHEARED OFF. THE TIP OF THE INNER SHAFT REMAINS WEDGED IN THAT APPLICATOR KNOB. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO GET THE IMPLANT HALFWAY IN AND TIGHTENED

  Patient problems: No Code Available

  MAUDE report 6448693 ↗