MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 5 DG, 9X8X23 MM; INTERBODY SPACERS

Model Number	188823408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A historical data review was conducted on the part number.A total of 5 complaints for unrelated issues were identified.There were no capas or non-conformances related to this part at the time of this review.As it was reported, the surgical procedure was completed and the incision closed prior to the adverse event occurrence.Additionally, the report also states "there was no defectiveness involved with the devices".No further information was provided by the complainant to assist with this investigation.Although the complainant clearly states that the event was not due to form, fit or, function of the implanted device a root cause is indeterminate.
Event or Problem Description
It was reported that this was a plif for treating spondylolisthesis (in one intervertebral lesion) on (b)(6) 2022.The procedure was completed without any issue.However, the patient's heart suddenly stopped during closing incision.They came to the following conclusions.There was no defectiveness involved with the devices.The heart stoppage did not become fatal.No further information is available.This complaint involves five (5) devices.

• Brand Name: CONCORDE PROTI 5 DG, 9X8X23 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 14688968
• Report Number: 3012966183-2022-00023
• Device Sequence Number: 5262703
• Product Code: MAX
• UDI-Device Identifier: 10705034352015
• UDI-Public: 10705034352015
• 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): 06/14/2022

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 Model Number: 188823408
• Device Catalogue Number: 186731745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/14/2022
• 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 Sex: Unknown