T-PAL 03.812.511Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034727974), received between Mar 31, 2017 and Jun 5, 2024 — classified as 4 malfunctions.

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 16, 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.

• MalfunctionJun 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024 , WHEN INSERTING THE SAMPLE CAGE, THE UPPER PART OF THE SAMPLE CAGE BROKE. THE REMAINING TIP WAS LEFT IN THE INSTRUMENT, BUT IT WAS REMOVED AFTER SURGERY. THE CAGE CAN NO LONGER BE USED. SURGERY WAS EXTENDED BY APPROXIMATELY 15 MINUTES DUE TO THE EVENT, AND WAS MANAGED WITH A SIMILAR PRODUCT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR A T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19470215 ↗
• MalfunctionAug 23, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT AFTER INSERTING THE TRIAL CAGE, WHEN TAKING THE TRIAL OUT, THE TRIAL WAS LEFT IN THE PATIENT. THE TRIAL WAS REMOVED FROM THE PATIENT. THERE WAS A SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353196 ↗
• MalfunctionDec 23, 2019Break; Break

  CONCOMITANT DEVICE: ADVANCE APPLICATOR INNER SHAFT ( PART# 03.812.521, LOT# UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9513045 ↗
• MalfunctionMar 31, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) SURGERY WAS PERFORMED ON (B)(6) 2017. DURING USING THE TRIAL IMPLANTS WITH TWO APPLICATORS, THEY BEGAN TO PIVOT INDEPENDENTLY, WHILST IN THE PATIENT, WITHOUT THE SURGEON TURNING THE APPLICATOR KNOB AS PER TECHNIQUE GUIDE. THEN, WHEN REMOVING THE TRIAL IMPLANTS, THEY BROKE, LEAVING THE BALL TIP INSIDE THE APPLICATOR KNOB. THE SAME HAPPENED BOTH INNER SHAFTS, WHILST HAMMERING THE IMPLANT INTO THE PATIENT. THE BALL TIP WAS BROKEN OFF INSIDE THE APPLICATOR KNOBS. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES WHILST A COMPETITOR SET WAS OPENED. THERE WAS NO PATIENT HARM AND THE OUTCOME WAS GOOD. ALL BROKEN OFF FRAGMENTS WERE REMOVED FROM THE PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT REPORTED PARTS: 2X APPLICATOR OUTER SHAFT (PART 03.812.001 LOT 8959881); 2X APPLICATOR KNOB (PART 03.812.004 LOT 9261316); 1X HAMMER (PART AND LOT UNKNOWN). THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450905 ↗