MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 5 DG, 9X8X27 MM; INTERBODY SPACER

Model Number	188827408
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned; therefore, a device evaluation was not possible.Lot 132722 was manufactured on 12/26/2018.All devices from the lot were manufactured per device specifications.There are no no-conformances or capas associated with this lot.Root cause cannot be determined or traced back to the device with the information provided.The complaint device was not returned for an evaluation.However, non-union is a known procedural risk for lumbar spinal fusion that is often caused by patient conditions that are entirely unrelated to device performance.
Event or Problem Description
It was reported that this was a plif (l5/s1) for spinal stenosis on (b)(6) 2022.The surgery was completed successfully with no surgical delay.After surgery, in (b)(6) 2023, a revision surgery due to non-union will be performed.In the revision surgery, the cages in question will be removed and replaced with different sized cages.Causes of the event are unknown.No further information is available.This complaint involves two (2) devices.

• Brand Name: CONCORDE PROTI 5 DG, 9X8X27 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: 17342308
• Report Number: 3012966183-2023-00013
• Device Sequence Number: 6941041
• Product Code: MAX
• UDI-Device Identifier: 00819917021288
• UDI-Public: 00819917021288
• 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): 07/18/2023

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: 12/26/2023
• Device Model Number: 188827408
• Device Catalogue Number: 188827408
• Device Lot Number: 132722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2018
• 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: Unknown