MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TCS; 3.5MM DIA, LOCKING BONE SCREW, 16MM

Model Number	5302-3516
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoskeleton® tcs surgical technique guide (60-0021 rev.04) and endoskeleton® tcs ifu (5346-0002 rev.08) states "create pilot holes for the screws using the appropriate length awl (relative to anticipated screw length usage) under a/p and lateral fluoroscopy".In addition, these state "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 a tcs awl guide was not used nor was the awl trajectory confirmed using fluoroscopy.Thus, the procedure performed contrary to the provided surgical technique.Due this along with the reported severe insertion angle, it is plausible that the pilot hole was created off axis.This lead 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 of the bone screw.A review of the device history records of the subject devices was completed.No anomalies or non-conformances were generated during the manufacture of these devices that would have led to this complaint condition.
Event or Problem Description
Delivered order form was received from (b)(6) medical center that indicated a locking collar fell off one of the 5302-316 locking bone screws.Follow up on the do form was completed and the following information was received in regards to locking collar falling off of the bone screw.The tcs bone screw was being advanced into the bone through the implant when the locking collar fell off.A tcs u-joint driver (p/n 5210-1024) was being used to inserter the bone screw.The tcs curved awl (p/n 5210-1063) was used to create the pilot hole for the bone screw.However, no fluoroscopy was used to confirm the trajectory of the pilot hole.In addition, no tcs awl guide was used due to the severe angle.The collar was removed from the operative site and the screw was left in without the collar.An acdf procedure was being performed and successfully completed.There was no harm to the patient as a result of the locking collar falling off.

• Brand Name: ENDOSKELETON® TCS
• Common Device Name: 3.5MM DIA, LOCKING BONE SCREW, 16MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6891593
• Report Number: 3006340236-2017-00011
• Device Sequence Number: 13618499
• Product Code: OVE
• UDI-Device Identifier: 00191375011521
• UDI-Public: (01)00191375011521(11)160301(10)V04(240)53023516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 5302-3516
• Device Catalogue Number: 5302-3516
• Device Lot Number: V04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention