T-PAL 03.812.311Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034727868), received between Apr 24, 2017 and Jun 4, 2024 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON APRIL 30, 2024, PRE-OPERATIVELY IT WAS NOTICED THAT THE BALL CLIP (DISTAL END) ON THE TWO INSTRUMENTS ARE MISSING, AND ONE OF WHICH WAS JAMMED IN THE HANDLE. THE DEVICE HAS NOT BEEN IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 11MM HEIGHT THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459900 ↗
• MalfunctionSep 16, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM NORWAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, TWO X25 TORQUE DRIVER WERE WORN OUT AND THE SURGEONS COULD NOT DO A FINAL TIGHTENING WITHOUT SLIPPING AND WEARING OUT THE SET SCREW. THE X25 INSERTER HAS LOST ITS CAPABILITY TO BE SELF-HOLDING OF THE SET SCREW AND IT KEPT LOOSING IT DURING SURGERY. THE TRIAL IMPLANT WAS BROKEN DURING SURGERY, AND A SMALL PART OF THE PROXIMAL PART WAS BROKEN OFF AND WAS INSIDE THE KNOB OF THE INSERTER. A SIMILAR PRODUCT WAS USED INSTEAD. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THIS REPORT IS FOR A T-PAL TRIAL SPACER 10MM X 28MM 11MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442074 ↗
• MalfunctionNov 4, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE CRANIAL SIDE OF THE TRIAL SPACER BROKE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN T-PAL OUTER SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 11MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785083 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A TRANSFORAMINAL POSTERIO ATRAUMATIC LUMBAR (T-PAL) SMALL TRIAL IMPLANT CAGE 11MM AND 10MM IN HEIGHT RESPECTIVELY BROKE OFF ON ITS ROUND TIP DURING A ONE LEVEL FIXATION PROCEDURE. THE BROKEN PART GOT STUCK IN AN UNKNOWN T-PAL INSERTER, HOWEVER, IT WAS TAKEN OFF WITH THE HELP OF THE SALES CONSULTANT TO LOOSEN THE PART THROUGH DEMONSTRATION. THE SURGERY WAS COMPLETED BY USING A NEW SMALLER TRIAL IMPLANT. THUS, THERE WAS A SURGICAL DELAY OF ABOUT 30 MINUTES. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN T-PAL INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8698070 ↗
• MalfunctionApr 24, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT L5-S1 ON (B)(6) 2017, THE BALL TIPPED END OF THE TRIAL SPACER BROKE OFF INTO THE APPLICATOR KNOB AS THE SURGEON WAS USING IT. THE BROKEN PIECE WAS RETRIEVED AND IT WAS CONFIRMED THAT THERE WAS NO ISSUE WITH THE APPLICATOR KNOB. A STANDARD X-RAY TAKEN DURING THE PROCEDURE CONFIRMED THAT THERE WERE NO ADDITIONAL FRAGMENTS. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE WITH THE SAME DEVICE WITHOUT ANY ILL EFFECTS TO THE PATIENT OR DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: T-PAL SPACER APPLICATOR KNOB (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) AND T-PAL SPACER APPLICATOR HANDLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6515392 ↗