MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 5DG 9 X 10 X 23MM; INTERBODY CONCORDE

Model Number	188823410
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A historical data review on the part number was conducted.There were no capas or non-conformance's related to the complaint type.There is insufficient information provided by the complainant.There was no evidence provided by the complainant to support an infection.Request for further information was sent to the complainant on (b)(6) 2021.There was no further information provided; therefore, the root cause is indeterminate.
Event or Problem Description
On (b)(6) 2021 plif (l4-5) was performed.The patient has medical history of dm.On (b)(6) the patient's back pain became worse.The crp value rose, and it did not seem that it would decrease.Therefore, the surgeon presumed that the patient might have become infectious.The patient underwent a removal procedure.Upon receipt of an examination result of bacteria, they will remove the cages in question.No further information is available.This complaint involves two (2) devices.

• Brand Name: CONCORDE PROTI 5DG 9 X 10 X 23MM
• Common Device Name: INTERBODY CONCORDE
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 12268947
• Report Number: 3012966183-2021-00019
• Device Sequence Number: 14562905
• Product Code: MAX
• UDI-Device Identifier: 00819917020946
• UDI-Public: 00819917020946
• 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): 08/03/2021

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: No Information
• Device Model Number: 188823410
• Device Catalogue Number: 188823410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR