T-PAL ProTi 360°Recalls & reported problems across all models
Tyber Medical, LLC · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 10 models of T-PAL ProTi 360° by Tyber Medical, LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2019 and Mar 20, 2025 — classified as 9 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported T-PAL ProTi 360° problems
Device problems
- Insufficient Device Problem Information7
- Migration5
- Expulsion3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Implant subsidence1
- Inaccurate Information1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Foreign Body In Patient3
- Failure of Implant1
- Hematoma1
- Limb Pain1
- Nervous System Injury1
T-PAL ProTi 360° models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- T-PAL™ ProTi 360°™ 108812007Intervertebral fusion device with bone graft, lumbar5 reports
- T-PAL™ ProTi 360°™ 108812009Intervertebral fusion device with bone graft, lumbar4 reports
- T-PAL™ ProTi 360°™ 108812010Intervertebral fusion device with bone graft, lumbar4 reports
- T-PAL™ ProTi 360°™ 108812008Intervertebral fusion device with bone graft, lumbar3 reports
- T-PAL™ ProTi 360°™ 108812208Intervertebral fusion device with bone graft, lumbar2 reports
- T-PAL™ ProTi 360°™ 108812011Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL™ ProTi 360°™ 108812207Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL™ ProTi 360°™ 108812209Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL™ ProTi 360°™ 108812210Intervertebral fusion device with bone graft, lumbar1 report
- T-PAL™ ProTi 360°™ 108812216Intervertebral fusion device with bone graft, lumbar1 report
Recent T-PAL ProTi 360° adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 28, 2023Expulsion; Expulsion
IT WAS REPORTED THAT THIS WAS A TLIF (L4-5) FOR SPONDYLOLYTIC SPONDYLOLISTHESIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE CAGE IN QUESTION HAD BEEN BACKED OUT. THE REVISION SURGERY WAS PERFORMED. THE POSSIBLE CAUSE OTHER THAN THE CAGE IS A SCREW FROM ANOTHER COMPANY WHICH WAS LOOSE, AND IT MIGHT CAUSE THE INTERVERTEBRAL SPACE TO MOVE AND THE CAGE TO BACK OUT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18409661 ↗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 ↗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 ↗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 ↗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 ↗InjuryMar 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THIS WAS A TLIF (L4 TO L5) FOR THE SPONDYLOLISTHESIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THE CAGE WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. IMPLANT DATE (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 16530776 ↗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 ↗MalfunctionAug 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT UNDERWENT A PRIMARY TLIF (L3/4) PROCEDURE ON (B)(6) 2021. THE CAGE IN QUESTION WAS APPLIED TO THE LESION. IT WAS CONFIRMED ON (B)(6), 2022 THAT THE CAGE HAD BACKED OUT BACKWARD. A REVISION PROCEDURE WAS COMPLETED WITH ANOTHER SUPPLIER'S CAGE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE(1) DEVICE.
Patient problems: Insufficient Information
MAUDE report 15233529 ↗MalfunctionMay 13, 2022Expulsion; Expulsion
ON (B)(6) 2022 THE PATIENT UNDERWENT A PRIMARY TLIF (L4-5) PROCEDURE WITHOUT SURGICAL DELAY. ON AN UNKNOWN DATE IT WAS FOUND THAT THE CAGE HAD BACKED OUT. ON (B)(6) THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE. THE SURGEON WONDERED IF THE CAGE MIGHT HAVE TRIGGERED THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14397556 ↗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 ↗MalfunctionSep 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
T WAS REPORTED THAT THIS WAS A TLIF (L4/5/S) FOR TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021. AFTER THE SURGEON INSERTED THE CAGE AT L5/S1, HE WAS NOT ABLE TO TURN THE CAGE DUE TO LIMITED INTERVERTEBRAL SPACE AND LESS INTERVERTEBRAL MOBILITY. SO HE TAPPED THE CAGE WITH A HAMMER. AS IMAGES SHOWED SOME AWKWARD SHAPES OF THE CAGE, IT WAS REMOVED FROM THE PATIENT'S BODY. THE CAGE HAD BROKEN, AND THE SURGEON TRIED TO REMOVE A FRAGMENT(S). HOWEVER, THE FRAGMENT(S) HAS BEEN LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS DELAYED OVER 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Insufficient Information
MAUDE report 12547485 ↗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 ↗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 ↗
Other Tyber Medical, LLC products
All Tyber Medical, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page