MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X11X28 MM; INTERBODY SPACER

Model Number	108812011
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Nervous System Injury (2689)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not received so physical evaluation was not possible.Dhr was reviewed.No issues found relating to the nature of the complaint.Lot was reviewed and no issues found contributing to the nature of the complaint.Lot met release requirements.No nonconformances in the lot are related to the nature of the complaint.Historical data review performed on this part number and lot number revealed no additional complaints received and three in-process qc inspection non-conformances for unrelated issues.The current complaint rate is 0.05% expulsion/migration can lead to death or serious injury but is often a result of external, non-device factors.The investigation could not establish a link between the device used the complaint reported.The device needs to be returned and radiographic imaging provided to establish the root cause.
Event or Problem Description
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.

• Brand Name: T-PAL PROTI 10X11X28 MM
• Common Device Name: INTERBODY SPACER
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: jeff zoleta ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 16674184
• Report Number: 3012966183-2023-00005
• Device Sequence Number: 5347566
• Product Code: MAX
• UDI-Device Identifier: 00819917021660
• UDI-Public: 00819917021660
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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 Expiration Date: 01/20/2025
• Device Model Number: 108812011
• Device Catalogue Number: 108812011
• Device Lot Number: 204880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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: Other
• Patient Sex: Male