T-PAL™ ProTi 360°™ 108812009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00819917021646), received between Mar 5, 2021 and Aug 2, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THIS WAS A TLIF (L4-5) FOR SPONDYLOLISTHESIS ON JANUARY 5, 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, IT WAS CONFIRMED THAT THE T-PAL WAS COMING LOOSE, AND THE 4 SCREWS WERE LOOSE. ON UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE T-PAL WAS REMOVED, AND THE 4 SCREWS WERE REPLACED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE CAUSE OF LOOSENING IS UNKNOWN. THE SURGEON'S COMMENT ON THIS EVENT IS NONE. THE PATIENT'S BONE QUALITY WAS FRAGILE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442815 ↗
• InjuryJul 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS WAS A TLIF (L5/S1) FOR SPINAL STENOSIS ON (B)(6) 2022. AFTER SURGERY, A REVISION SURGERY WILL BE PERFORMED IN (B)(6) 2023 DUE TO LOOSENING OF THE SCREWS AND NON-UNION BETWEEN L5/S1. IN THE REVISION SURGERY, THE CAGE WILL BE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT. THE SCREWS WILL BE REMOVED AND REPLACED WITH SIZED UP SCREWS. THE SURGEON COMMENTED IT WAS UNCLEAR IF LOOSENING OF THE SCREWS OCCURRED BECAUSE OF NON-UNION OR IF LOOSENING OF THE SCREWS CAUSED NON-UNION. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 17380467 ↗
• InjurySep 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  T WAS REPORTED THAT THIS WAS A TLIF (L5/S1) FOR LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021. THE CAGE WAS INSERTED INTO THE INTERVERTEBRAL DISK. THEN, THE CAGE BROKE THROUGH THE ANTERIOR LONGITUDINAL LIGAMENT AND MOVED TO THE ANTERIOR SIDE. THE CAGE WAS REMOVED AND REINSERTED LESS THAN 30- MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 12519610 ↗
• MalfunctionMar 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  FOR THE CASE ON (B)(6) 2021, A 9MM PROTI CAGE 108812009 (206128 LOT) NEEDED TO BE CONDEMNED AS THE CAGE DISENGAGED FROM THE APPLICATOR. PARTS OF THE APPLICATOR ARE LISTED AS FOLLOWS, APPLICATOR INNER SHAFT (03.812.003) + APPLICATOR OUTER SHAFT (03.812.001)+ APPLICATOR KNOB (03.812.004). THE SURGEON INSERTED APPLICATOR WITH 9MM PRO-TI CAGE. A STANDARD PROCEDURE WAS FOLLOWED, THE CAGE WAS FIRST INSERTED IN A LOCKING STATE, THE TURNED THE KNOW TO OPEN FOR TURNING THE CAGE. AS THE POSITION OF THE CAGE WAS SLIGHTLY ANTERIOR. SO SURGEON DECIDED TO USE A SLIDE HAMMER TO MOVE THE CAGE IN POSTERIOR DIRECTION. THE SLIDE HAMMER WAS OPERATED IN A GENTLE AND CONTROLLED FORCE. YET, SUDDENLY, THE CAGE DETACHED FROM THE APPLICATOR. REMOVAL TOOL WAS ATTEMPT TO GRAB THE IMPLANT, YET, THERE WAS NOT ENOUGH SPACE TO INSERT THE REMOVAL TOOL. THE DISENGAGED IMPLANT WAS REMOVED FROM ANTERIOR APPROACH THROUGH ANOTHER INCISION. SYNFIX EVOLUTION WAS USED TO FUSE L5-S1. SURGEON WOULD LIKE US TO INVESTIGATE WHY THE CAGE DISENGAGED FROM THE APPLICATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423326 ↗