MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TCS LOCKING BONE SCREW 3.5MM, 18MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	5302-3518
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 22-feb-2018 as regulatory report # 3006340236-2017-00019 ¿ 1 with "follow-up" marked per request, it is being resubmitted as an initial report.The endoskeleton tcs surgical technique guide and ifu states "create pilot holes for the screws using the appropriate length awl (relative to anticipated screw length usage) under a/p and lateral fluoroscopy.The awl guide must be used to help facilitate the desired pilot hole trajectory and position.Confirm desired awl trajectory prior to awl advancement using fluoroscopy." it was reported that the tcs awl guide was not used nor was the awl trajectory confirmed using fluoroscopy.Thus the procedure was performed contrary to the instructions.Due to this along with the reported severe insertion angle, it's plausible that the pilot hole was created off axis.This led to the tcs locking bone screw being inserted at an inappropriate angle which caused the locking collar to be obstructed by the implant during insertion.This caused the locking collar to expand and fall off the bone screw.A review of the dhr was completed.No anomalies or non-conformances were generated during the manufacture of these devices that would have led to this complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the locking collar fell off the screw body and could not be used while inserting the screw.A different screw was able to be used and the planned c5/6 procedure was able to be completed.The screw was discarded at the hospital.There were no reported adverse effects to the patient.

• Brand Name: ENDOSKELETON TCS LOCKING BONE SCREW 3.5MM, 18MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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: 7290499
• Report Number: 3006340236-2017-00019
• Device Sequence Number: 14062779
• Product Code: OVE
• UDI-Device Identifier: 00191375011545
• UDI-Public: 00191375011545
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151596
• 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: 5302-3518
• Device Catalogue Number: 5302-3518
• Device Lot Number: V09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2016
• 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
• Patient Sex: Unknown