MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON® TCS; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	5302-3516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was not available.The subject device was discarded.Therefore, the subject device was not returned to the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a spinal device being used for an anterior cervical discectomy and fusion (c3-5) case.It was reported that there was a malfunction with the locking screw; the little collar on the locking screw came off while the screw was being inserted.After the locking screw was placed in the patient, the physician noticed that the little collar piece had popped off the screw.To resolve this issue, the physician removed the collar piece and the screw, and another screw was used in its place.There were no patient symptoms or complications as a result of this event, and none are anticipated.

• Brand Name: ENDOSKELETON® TCS
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• MDR Report Key: 9765123
• Report Number: 3006340236-2020-00001
• Device Sequence Number: 2496661
• Product Code: OVE
• UDI-Device Identifier: 00191375011521
• UDI-Public: 00191375011521
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K151596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 5302-3516
• Device Catalogue Number: 5302-3516
• Device Lot Number: V45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR