MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 360; INTERBODY SPACER SYSTEM

Model Number	108812010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.However, x-ray images as well as extensive patient history, both pre- and post-operatively, have been provided and evaluated.A medical assessment of this complaint was also completed.Based on the information provided, it can be determined that there were no issues with the implant or instrumentation used in the procedure.The procedure was successful and resulted in fusion.The adjacent level disc degeneration reported in the complaint is likely a result of the patient's medical history.A review of the lot was conducted and found one non-conformance unrelated to this specific complaint type.The parts were scrapped and the lot met released requirements.Complaints of this nature are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.No further action is required at this time.(b)(4).
Event or Problem Description
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.

• Brand Name: T-PAL PROTI 360
• Common Device Name: INTERBODY SPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 11385080
• Report Number: 3012966183-2021-00002
• Device Sequence Number: 2190801
• Product Code: MAX
• UDI-Device Identifier: 00819917021653
• UDI-Public: 00819917021653
• Combination Product (Y/N): N
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 108812010
• Device Catalogue Number: 108812010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR