MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X7X28 MM; INTERBODY SPACERS

Model Number	108812007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
No capas or non-confomrnaces related to this complaint issue were found during device history record review.The device portion not remaining in the patient was not returned for evaluation.The root cause is indeterminate.

• Brand Name: T-PAL PROTI 10X7X28 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: jeff zoleta ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8867610933
• MDR Report Key: 16131630
• Report Number: 3012966183-2022-00038
• Device Sequence Number: 3327080
• Product Code: MAX
• UDI-Device Identifier: 00819917021622
• UDI-Public: 00819917021622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/10/2023

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: 108812007
• Device Catalogue Number: 108812007
• Device Lot Number: 242909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown