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

Model Number	5210-1021
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 21-feb-2018 as regulatory report # 3006340236-2017-00028 ¿ 1 with "follow-up" marked.Per request, it is being resubmitted as an initial report.The tcs implant inserter was sent back to the titan spine contract distribution center.At the titan spine contract distribution center, the tcs inserter was inspected and was found to be conforming to specification.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during an acf c5-c6 level surgery, the surgeon had some trouble disengaging an implant.The surgeon experienced cross threading between the threaded inserter and the implant, making the disengagement between the two difficult.Once the surgeon disengaged the implant, he did not like the fit of the implant inside the patient's disc space.The surgeon removed that implant and used another implant instead which was satisfactory.The surgery was completed successfully.There was no reported adverse effect to the patient.

• Brand Name: ENDOSKELETON TCS INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w. executive dr. suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7287683
• Report Number: 3006340236-2017-00028
• Device Sequence Number: 2437519
• Product Code: LXH
• UDI-Device Identifier: 00191375011873
• UDI-Public: 00191375011873
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: 5210-1021
• Device Catalogue Number: 5210-1021
• Device Lot Number: Y160519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/21/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown