MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE® PROTI 360°¿; CONCORDE PROTI P, 9X11X23 MM

Model Number	188823111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted for an event that was identified as part of a historical data review comparing clinical study adverse event with the vigilance system.The complaint was investigated and evaluated without the associated device, as it remains implanted.Event reported as part of a clinical study.No lot information was provided; therefore, a device history record review was unable to be performed.Clinician did not note any implications of defect or failures related to the implanted device.A historical data review and trend analysis was conducted revealing no current trends or capas related to the nature of this complaint.
Event or Problem Description
Event was identified as part of a retrospective clinical study: at 15 months post operative, the subject was radiographically fused with grade 3 graft incorporation but had caudal subsidence.

• Brand Name: CONCORDE® PROTI 360°¿
• Common Device Name: CONCORDE PROTI P, 9X11X23 MM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 21414764
• Report Number: 3012966183-2025-00002
• Device Sequence Number: 21168502
• Product Code: MAX
• UDI-Device Identifier: 00819917020786
• UDI-Public: 00819917020786
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 188823111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 79 KG