MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	4200-1040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient with lumbar ddd with stenosis for tlif titan tt technique spinal therapy.It was reported that inserter was impacted with a mallet and the articulating tip broken at the distal joint.The distal portion remained threaded to the implant but was removed without incident.There was no patient symptoms or complications as a result of this event.

• Brand Name: ENDOSKELETON TT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• MDR Report Key: 11600948
• Report Number: 3006340236-2021-00006
• Device Sequence Number: 14566684
• Product Code: LXH
• UDI-Device Identifier: 00191375002994
• UDI-Public: 00191375002994
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 4200-1040
• Device Catalogue Number: 4200-1040
• Device Lot Number: N140923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1