T-PAL™ ProTi 360°™ 108812010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00819917021653), received between Nov 4, 2020 and Jun 28, 2023 — classified as 2 injuries, 2 malfunctions.

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

• InjuryJun 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2023. AFTER SURGERY, THE PROTI T-PAL WAS FOUND TO BE SLIGHTLY BACKED OUT. ON (B)(6) 2023, A REMOVAL SURGERY WAS PERFORMED AND THE PROTI T-PAL WAS REMOVED. THE AFFECTED AREA WAS RE-FIXED WITH A CAGE THAT WAS 1 MM HIGHER THAN THE ONE PREVIOUSLY USED. IT WAS ALSO FOUND THAT THE SCREW AT S1 WAS LOOSE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216781 ↗
• MalfunctionJan 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SUBSEQUENT TO THE HEMATOMA REMOVAL PROCEDURE REPORTED UNDER (B)(4), THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 AS FOLLOWS: 199725740S CFX SCREWS (2 PCS.) DEPLOYED AT L6 HAD BEEN LOOSE. THESE SCREWS WERE REPLACED. 108812010 CAGE (1 PC.) HAD COME OFF. THE CAGE WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS (B)(4) IS RELATED TO (B)(4) AS FOLLOWS: (B)(4): ABOUT EVENTS IN THE REVISION PROCEDURE ON (B)(6) 2021. (B)(4): ABOUT POSTOPERATIVE HEMATOMA ON (B)(6) 2021.

  Patient problems: Hematoma

  MAUDE report 13151358 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT TLIF PROCEDURE AT L4/L5 WITH INFUSE AND LOCAL AUTOGRAFT. POST-OPERATIVE TREATMENT INCLUDED PHYSICAL THERAPY AND PAIN MEDICATION. 9 MONTH, 10.5 MONTH, AND 13 MONTH FOLLOW-UP POST-SURGERY SHOWED LORDOSIS OF THE LUMBAR SPINE, GRADE 1 RETROLISTHESIS OF L2 RELATIVE TO L3 AND L3 RELATIVE TO L4. ADDITIONALLY L2-L3 HAD A SMALL CENTRAL DISC EXTRUSION AND MILD TO MODERATE FORAMINAL STENOSIS, LIKELY RESULTING IN RIGHT L3 RADICULOPATHY. 13 MONTHS AFTER SURGERY, ADDITIONAL EVALUATIONS REVEALED L3-L4 LEVEL WITH DIFFUSE DISC BULGE, PARACENTRAL TO THE RIGHT WITH NEUROFORAMINAL STENOSIS. AT THAT TIME, IT WAS DECIDED TO HAVE AN OBLIQUE LUMBER INTERBODY FUSION FROM L2-L4, WITH POSTERIOR PERCUTANEOUS INSTRUMENTATION FROM L2-L5 WITH REMOVAL OF INSTRUMENTATION FROM L4-L5. PATIENT IS PLANNED TO UNDERGO SURGERY FOR THE ADJECT LEVEL DEGENERATION. HOWEVER, THE PROCEDURE HAS NOT YET BEEN SCHEDULED. THE SURGEON NOTED THAT THE PATIENT SHOWED INDICATION OF ADJACENT LEVEL DEGENERATION PRIOR TO THE TLIF PROCEDURE.

  Patient problems: Pain

  MAUDE report 11385080 ↗
• MalfunctionNov 4, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  "FOR THE CASE ON (B)(6) 2020, A 10MM PROTI CAGE (108812010 LOT) NEEDED TO BE CONDEMNED AS THE CAGE DISENGAGED FROM THE ADVANCED APPLICATOR. PARTS OF THE ADVANCED APPLICATOR ARE LISTED AS FOLLOWS, ADVANCED APPLICATOR INNER SHAFT (03.812.521) + ADVANCED APPLICATOR OUTER SHAFT (03.812.520)+ APPLICATOR KNOB (03.812.004). THE SURGEON USED APPLICATOR FOR 10 MM TRIAL IN L5-S1, THE APPLICATOR KNOB COULDN'T BE TURNED AND COMPLAINED THE APPLICATOR END WAS TOO BULKY AND REQUESTED TO CHANGE TO ADVANCED APPLICATOR FOR 10MM TRIAL AND THE IMPLANT. A GREAT RESISTANCE WAS ENCOUNTERED WHEN THE 10MM PROTI CAGE WAS BEING INSERTED. LITTLE PROGRESS WAS OBSERVED EVEN SURGEON HAMMERED HARDLY WITH MALLET. THEN THE SURGEON TURNED THE APPLICATOR KNOB TO AN OPEN POSITION FOR THE IMPLANT TO TURN. SURGEON THEN HAMMERED AGAIN TO TURN THE PROTI CAGE. THE CAGE STARTED TO TURN AS SHOWN IN XRAY, SURGEON HAMMERED HARDLY SEVERAL TIMES IN ORDER TO FULLY TURN THE CAGE. SUDDENLY, THE CAGE BROKE THROUGH THE ANTERIOR ANNULUS AND WENT ANTERIORLY. SURGEON GRABBED THE ADVANCED APPLICATOR AND FOUND THAT IT HAS ALREADY DETACHED FROM THE CAGE. REMOVAL TOOL WAS ATTEMPT TO GRAB THE IMPLANT, YET, IT WAS LOCATED TOO ANTERIORLY WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10784610 ↗