T-PAL 03.812.515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034728018), received between Jan 6, 2020 and Mar 20, 2020 — classified as 2 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 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.

• MalfunctionMar 20, 2020Break; Break

  THE ISSUE WAS DISCOVERED DURING DECONTAMINATION AT THE STERILIZATION DEPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862450 ↗
• MalfunctionJan 6, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HUNGARY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR AN INTER-VERTEBRAL DISC REMOVAL. THE INNER SHAFT (OF THE TPAL) WITH LARGE 15 SIZED(PURPLE) IMPLANT PROBE ENDING DAMAGED DURING SURGERY. THE BALL TIP DISTAL ENDING OF THE INSTRUMENT HAS BROKEN, AND THE SURGEON COULD NOT USE IT ANYMORE, HE HAD TO TAKE IT OUT OF THE PATIENT. THE IMPLANTATION WAS SUCCESSFUL, AND THE BALL TIP ENDING IS REMAINED IN THE INSTRUMENT., THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: TPAL SPACER APPLICATOR HANDLE (03.812.001, LOT#UNKNOWN, QUANTITY 1), TPAL SPACER APPLICATOR KNOB (03.812.004 ,LOT#UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552930 ↗