MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X8X28 MM; INTERBODY SPACERS

Model Number	108812008
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot, imaging, or surgical information was provided.The user suggested the pedicle screw system used was loose during removal indicating the posterior fixation used was inadequate.However, without either device's information, the root cause cannot be appropriately established.
Event or Problem Description
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.

• Brand Name: T-PAL PROTI 10X8X28 MM
• Common Device Name: INTERBODY SPACERS
• 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18409661
• Report Number: 3012966183-2023-00031
• Device Sequence Number: 15645239
• Product Code: MAX
• UDI-Device Identifier: 00819917021639
• UDI-Public: 00819917021639
• 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: 2022
• 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): 12/28/2023

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 Model Number: 108812008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 68 YR
• Patient Sex: Unknown