MAUDE Adverse Event Report: TITAN SPINE MEQUON RESEARCH CENTER ENDOSKELETON TT INTERBODY SYSTEM; DRIVER, PROSTHESIS

Model Number	4200-1036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding an instrument used for fusion therapy.It was reported that the inserter was broken off when being malleted into the patient.There was no fragment left or contact with the patient.There were no symptoms reported.There were no further complications reported regarding the event.

• Brand Name: ENDOSKELETON TT INTERBODY SYSTEM
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): TITAN SPINE MEQUON RESEARCH CENTER; 6140a west executive drive; mequon WI 53092
• MDR Report Key: 11617388
• Report Number: 3006340236-2021-00007
• Device Sequence Number: 3086022
• Product Code: HWR
• UDI-Device Identifier: 00191375030201
• UDI-Public: 00191375030201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 4200-1036
• Device Catalogue Number: 4200-1036
• Device Lot Number: Y191207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1