MAUDE Adverse Event Report: TYBER MEDICAL T-PAL¿ PROTI 360°¿; T-PAL PROTI 10X7X28 MM

Model Number	108812007
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The event was identified as part of a retrospective clinical study and was investigated without the impacted device.No lot information was made available; therefore, a lot-specific device record review was unable to be conducted.A historical data review concluded no identified trends.The clinician determined that the subject was radiographically healed and returned to normal activity at 17 months post-op with no further complications.The root cause cannot be established with the available information.If further relevant information becomes available, a supplemental submission shall be made.

• Brand Name: T-PAL¿ PROTI 360°¿
• Common Device Name: T-PAL PROTI 10X7X28 MM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017
• MDR Report Key: 21654365
• Report Number: 3012966183-2025-00007
• Device Sequence Number: 18017203
• Product Code: MAX
• UDI-Device Identifier: 00819917021622
• UDI-Public: 00819917021622
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 108812007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 49 KG