MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 5 DG, 9X11X27 MM; INTERBODY SPACER

Model Number	188827411
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic imaging, device/lot information, and any other information used to determine the root cause of the complaint was not provided at this time.Therefore the conclusion of the investigation is "cause not established".
Event or Problem Description
The patient underwent a tlif procedure (5/s) on (b)(6) 2022.It was found on an unknown date that the cage had backed out.The patient is scheduled to undergo a revision procedure on (b)(6).No further information is available.This complaint involves one (1) device.

• Brand Name: CONCORDE PROTI 5 DG, 9X11X27 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8668899914
• MDR Report Key: 15182741
• Report Number: 3012966183-2022-00028
• Device Sequence Number: 6389796
• Product Code: MAX
• UDI-Device Identifier: 00819917021318
• UDI-Public: 00819917021318
• 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): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188827411
• Device Catalogue Number: 188827411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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