MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TCS 3.5MM DIA LOCKING BONE SCREWS, 14MM

Catalog Number	5302-3514
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a retrospective medical device report for a complaint on the subject device.It was determined this complaint required a medical device report after a review of medical device report determination procedures.Patient information is not available for this report.A review of the device history records was performed for the subject device.The review revealed there were no anomalies or discrepancies were noted within the device history records for the product of the subject device lot.All records showed product met specifications and passed the incoming inspection.The tcs drivers are designed to fail before the tcs bone screws under pure torsion as was observed in design validation.The screw head will only break first if the driver is apply a bending force to the screw.
Event or Problem Description
While performing an acdf c4-c7 procedure to implant a tcs 7mm medium implant (p/n 5366-1407 lot# a141204), the surgeon had a locking collar come off of one screw and the screw head break off another screw.The screw failures occurred when the surgeon was advancing the screws with a tcs swivel driver.Prior to seating the screws, a tcs curved awl was used to create the pilot holes.The surgeon was able to successfully finish the procedure at c6/c7 with using different screws.C6/5 was auto fused and the surgeon chose to use a different company implant at c4/5.No harm came to the patient due to the screw failures; however, surgery was delayed for approximately 15 minutes.

• Brand Name: ENDOSKELETON® TCS 3.5MM DIA LOCKING BONE SCREWS, 14MM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5397018
• Report Number: 3006340236-2015-00015
• Device Sequence Number: 450858
• Product Code: OVE
• UDI-Device Identifier: M682530235140
• UDI-Public: +M682530235140/$V01/16D20141205U
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Report Date (Section B): 01/26/2016

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: Physician
• Device Catalogue Number: 5302-3514
• Device Lot Number: V01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1