MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 12X9X32 MM; INTEBODY SPACER

Model Number	108812209
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent a primary tlif (l3/4) procedure on (b)(6) 2021.The cage in question was applied to the lesion.It was confirmed on (b)(6), 2022 that the cage had backed out backward.A revision procedure was completed with another supplier's cage.No further information is available.This complaint involves one(1) device.
Additional Manufacturer Narrative
The manufacturing dhr was reviewed with no issues found.Lot met release requirements.No nonconformances in the lot are related to the nature of the complaint.Without the device or imaging, it could not be determined if the issue was device related.While expulsion can lead to serious injury, it is often a result of trauma, poor bone quality, or poor supplementary fixation.The device lot information provided was reviewed and no issues identified related to the failure mode of the implant.However, the device and radiographic images were not provided so no conclusion could be reached.

• Brand Name: T-PAL PROTI 12X9X32 MM
• Common Device Name: INTEBODY 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 15233529
• Report Number: 3012966183-2022-00027
• Device Sequence Number: 20409368
• Product Code: MAX
• UDI-Device Identifier: 00819917021752
• UDI-Public: 00819917021752
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2022

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: 06/02/2025
• Device Model Number: 108812209
• Device Catalogue Number: 108812209
• Device Lot Number: 204882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown