MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI P, 9X7X23 MM; INTERBODY SPACERS

Model Number	188823107
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a tlif (l4/5) performed on (b)(6) 2023.The surgery was completed successfully with no surgical delay.After surgery, asd occurred.A revision surgery to extend fixation is scheduled for (b)(6) 2023.No further information is available.
Additional Manufacturer Narrative
A total of 145 parts were produced at tyber medical.Three devices were rejected at final inspection, and the remaining 142 were packaged and sterilized.All released parts conform to device specification.There are no other non-conformances or relevant capas associated with this lot.The device was not returned so a device evaluation was not possible.Root cause cannot be traced back to the device with the information provided.Asd is a known procedural risk for lumbar spinal fusion that is often caused by patient conditions that are entirely unrelated to device performance.Root cause cannot be traced to the device.
Event or Problem Description
It was reported that this was a tlif (l4/5) performed on (b)(6) 2023.The surgery was completed successfully with no surgical delay.After surgery, asd occurred.A revision surgery to extend fixation is scheduled for (b)(6) 2023.No further information is available.

• Brand Name: CONCORDE PROTI P, 9X7X23 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 17987725
• Report Number: 3012966183-2023-00019
• Device Sequence Number: 8171816
• Product Code: MAX
• UDI-Device Identifier: 00819917020748
• UDI-Public: 00819917020748
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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
• Device Expiration Date: 06/04/2025
• Device Model Number: 188823107
• Device Lot Number: 20099AX01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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