T-PAL™ ProTi 360°™ 108812011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917021660), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Expulsion” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2023Expulsion; Expulsion

  IT WAS REPORTED THAT THIS WAS A TLIF (L4/5) FOR SPINAL STENOSIS ON (B)(6), 2023. BASED ON PREOPERATIVE MEASUREMENTS, THE PLANNED SIZE OF A PRODUCT WAS TO BE AROUND 13 MM. THE AFFECTED SITE WAS OPENED IN THE ORDER OF 7 MM, 8 MM, 9 MM, 10 MM, 11 MM, AND 12 MM USING A DISK SPREADER. THE SURGEON DETERMINED THAT IT WOULD BE DIFFICULT TO USE A PRODUCT WITH A HEIGHT OF 11 MM OR LARGER BECAUSE OF ABNORMAL NERVE ROOT RUNNING. THE SURGEON DONE A TRIAL AND DETERMINED TO USE THE T-PAL WITH A HEIGHT OF 11 MM. AFTER INSERTING THE T-PAL, COMPRESSION WAS APPLIED WITH SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, THE PATIENT HAD SYMPTOMS, AND WHEN DIAGNOSTIC IMAGING WAS PERFORMED, IT WAS FOUND THAT THE T-PAL WAS BACKED OUT. DUE TO CONTACT BETWEEN THE T-PAL AND THE NERVE, IT WAS DECIDED THAT AN EMERGENCY REOPERATION WOULD BE PERFORMED ON (B)(6), 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nervous System Injury

  MAUDE report 16674184 ↗