T-PAL™ ProTi 360°™ 108812208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917021745), received between Feb 10, 2020 and Jun 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (1 report).

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.

• MalfunctionJun 10, 2021Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THERE WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE CAGE DEPLOYMENT, THE SURGEON DID NOT NOTICE THAT THE HOLDER HAPPENED TO LEAN OUTWARD. WITHOUT NOTICING THAT HE TAPPED THE CAGE. THEN THE CAGE BROKE. BECAUSE THE CAGE HAD BEEN DEPLOYED DEEP IN THE INTERVERTEBRAL LESION, HE DECIDED NOT TO EXTRACT IT. THE PROCEDURE WAS COMPLETED IN LESS THAN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11977266 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  01/10/2020 UPDATED EVENT DESCRIPTION: ON (B)(6) 2019 MIS-TLIF PROCEDURE WAS PERFORMED TO TREAT SPINAL CANAL STENOSIS IN L5-S1. AN X-TAB AND THE PROTI T-PAL LARGE (108812208) WERE IMPLANTED DURING THE PROCEDURE. AFTER DECOMPRESSION WAS PERFORMED, THE SURGEON MOVED ON TO INTERVERTEBRAL DISC DISSECTION. THE IMPLANTS SEEMED TO HAVE BEEN LOCATED SLIGHTLY OFF TO THE POSTERIOR DIRECTION, BUT IT WAS CONFIRMED THAT THE IMPLANTS WERE SECURED TO THE VERTEBRAL BODY. THE SURGEON IMPLANTED A ROD(S) AND COMPLETED FINAL FIXATION OF SCREWS. THE PATIENT WAS X-RAYED POSTOPERATIVELY, AND IT WAS CONFIRMED THAT THE IMPLANTS HAD BEEN SECURED IN PLACE. ON (B)(6) 2020 IT WAS CONFIRMED THAT THE PROTI T-PAL LARGE IN QUESTION HAD BACKED OUT TO THE POSTERIOR DIRECTION. THE SURGEON COMMENTED THE FOLLOWING: THIS ADVERSE EVENT MIGHT HAVE PUT PRESSURE ON THE NERVE. THE ENDPLATES WERE CRASHED WHICH MIGHT HAVE CREATED A GAP BETWEEN THE PROTI T-PAL LARGE. THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2020. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). U

  Patient problems: Foreign Body In Patient

  MAUDE report 9688632 ↗