MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 5 DG, 9X10X27 MM; INTERBODY SPACERS

Model Number 188827410

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

No problems found with the device histroy record review.No capas or non-conformances identified.

Event Description

It was reported that this was an unknown surgery on (b)(6) 2020.After the surgery, asd(adjacent segment disease) occurred.The reoperation to extend fixation will be performed on (b)(6) 2023.No further information is available.

• Brand Name: CONCORDE PROTI 5 DG, 9X10X27 MM
• Type of Device: 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18301592
• MDR Text Key: 330173308
• Report Number: 3012966183-2023-00029
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00819917021301
• UDI-Public: 00819917021301
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 188827410
• Device Lot Number: 159320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other