T-PAL™ ProTi 360°™ 108812007Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00819917021622), received between Oct 23, 2019 and Mar 20, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Implant subsidence; Implant subsidence

  EVENT IDENTIFIED AS PART OF A RETROSPECTIVE CLINICAL STUDY. PATIENT DIAGNOSED WITH RADICULOPATHY, STENOSIS, BACK & LEG PAIN (GREATER THAN 6 MONTHS), RIGHT AND LEFT HAFFMAN: PRESENT (GREATER THAN 6 MONTHS). AT 4 WEEKS POST OP THE SUBJECT HAD ONSET OF LEFT LEG AND FOOT PAIN. THE SURGEON DISCUSSED REMOVING CAGE WITH MAINTAINING PEDICLE SCREWS IN POSITION. AT 2 MONTHS POST OPERATIVE THE SUBJECT UNDERWENT A REVISION SURGERY. THIS EVENT WAS CONTINUOUS, HAD MODERATE SYMPTOMS, WAS SERIOUS, AND HAD A POSSIBLE RELATIONSHIP TO THE SUBJECT DEVICE. HOSPITALIZATION WAS REQUIRED (PATIENT SPENT 4 DAYS IN THE HOSPITAL) BUT THE PATIENT RECOVERED WITHOUT SEQUELAE. THE REVISION SURGERY WAS DONE DUE TO S/P LUMBAR FUSION, ABNORMAL MRI, LUMBAR SPINE RADICULOPATHY, AND SCOLIOSIS WITH SUBSIDENCE.

  Patient problems: Limb Pain

  MAUDE report 21654365 ↗
• InjuryNov 17, 2023Migration; Migration

  IT WAS REPORTED THAT THIS WAS A POSTERIOR LUMBAR INTERBODY FUSION (L5/S) FOR SPINAL CANAL STENOSIS ON (B)(6) 2023. IN THE SURGERY, FOR L5/S FUSION, THE L5/S INTERVERTEBRAL SPACE WAS NARROW, ONLY ABOUT 7 MM OR LESS, AND THE SURGEON EXTENDED IT TO 9 MM. THE SHARP SPOON WAS ALSO A LITTLE DEEPER DURING THE INTERVERTEBRAL DISSECTION. THE SURGEON INSERTED THE CAGE (108812007) 7 MM, BUT THE CAGE FELL OUT ANTERIORLY DURING INSERTION. HE TRIED TO PUT IT BACK ONCE BUT COULDN'T. INTRAOPERATIVE IMAGING CONFIRMED THE ANTERIOR MEDIAN DROPOUT. HE DECIDED THAT IT WOULD BE IMPOSSIBLE TO REMOVE THE CAGE FROM THE REAR. L5/S WAS FIXED WITH PPS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON COMMENTED THAT HE MIGHT OVEREXTENDED THE VERTEBRAE A BIT. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18160985 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON UNKNOWN DATE, WHILE INSERTING THE T-PAL PROTI INTERBODY, THE CAGE BROKE IN HALF INSIDE OF THE L2-L3 DISC SPACE. THE HALF OF THE CAGE THAT BROKE INSIDE THE PATIENT DISC SPACE WAS LEFT. THERE WAS NO SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16131630 ↗
• MalfunctionJan 7, 2021Migration; Migration

  ON (B)(6) 2019, THE PRIMARY MIS-TLIF PROCEDURE L5/S WAS PERFORMED TO TREAT LUMBAR DEGENERATIVE SPONDYLOLISTHESIS. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. ON (B)(6) 2020, THE FOLLOWING EVENTS WERE REPORTED: THE CAGE AT L5/S1 HAD BACKED OUT. THE SCREW AT S1 RIGHT HAD BROKEN OFF. THE PATIENT UNDERWENT A REVISION PROCEDURE WHICH SUCCEEDED WITHOUT FURTHER ISSUES. THE SURGEON COMMENTED THE FOLLOWING: THE CAGE MIGHT HAVE BECOME LOOSE WHICH RESULTED IN THE BACK-OUT BEFORE BONE HEALING. THE BACK-OUT MIGHT HAVE PUT EXTRA LOAD TO THE SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO DEVICES.

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

  MAUDE report 11132482 ↗
• MalfunctionOct 23, 2019Migration; Migration

  ON (B)(6) 2019, A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE (L4-5 STABILIZATION) TREATING SPINAL STENOSIS WAS PERFORMED WITHOUT A SURGICAL DELAY. WITH REGARD TO THE INITIAL PROCEDURE, THE SURGEON COMMENTED AS FOLLOWS: IT TOOK MORE TIME TO INSERT THE TITANIUM CAGE IN QUESTION COMPARED TO A PEEK CAGE. S/HE HAMMERED MORE THAN USUAL FOR INSERTING THE CAGE. ON (B)(6) 2019, IT WAS REPORTED THAT THE CAGE (108812007) HAD BACKED OUT. CURRENTLY, THE PATIENT FEELS PAIN. THE SURGEON EVALUATED THE ADVERSE EFFECT AS "MILD TO MODERATE SEVERITY." S/HE ALSO POINTED OUT THAT THE PATIENT'S BONE QUALITY WAS LESS SUSTAINABLE. THE PATIENT WILL UNDERGO A REVISION SURGERY ON (B)(6) 2019. THE INITIAL IMPLANT DATE WAS (B)(6) 2019. EXPLANT DATE (B)(6) 2019. PRODUCT CODE: 1088-12-007, LOT NUMBER 112210. HOSPITAL: (B)(6) HOSPITAL DEVICE IS NOT EXPECTED TO BE RETURNED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 9224678 ↗