MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TCS 3.8MM DIA, LOCKING BONE SCREW, 14MM

Catalog Number	5302-3814
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
Additional Manufacturer Narrative
A review of the device history record was performed for the subject device.The review revealed the device was conforming to the initial inspection record and there were no issues during the manufacture of the product that would contribute to this complaint condition.The tcs surgical technique guide was reviewed.The review revealed the surgical technique states "the awl guide must be used to help facilitate the desired pilot hole trajectory and position".Thus, the surgeon did not follow the procedure when creating the pilot hole.This caused the bone screw to be inserted at an improper trajectory leading to the bone screw's locking collar contacting the cage of the implant.This contact likely caused the locking collar to bend to a diameter greater than the bone screw.As a result, the locking collar fell off of the bone screw.Device was disposed of by hospital.
Event or Problem Description
During a multi-level case, the surgeon used a curved fixed awl without the awl guide to drill the pilot holes.The superior level screws gave the surgeon difficulty installing.When the tcs locking bone screws reached approximately half way in, the screws began to press against the tcs implant cage as the pilot hole angle was deep.This caused the locking collars of the bone screws to fall off.The surgeon recovered the locking collars with a bayonet forceps.The rescue screw extractor was used to remove the screws.The procedure was finished using additional bone screws with no further complications.There was no harm to the patient as a result of the locking collars falling off of the bone screws.

• Brand Name: ENDOSKELETON® TCS 3.8MM DIA, LOCKING BONE SCREW, 14MM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5718293
• Report Number: 3006340236-2016-00003
• Device Sequence Number: 17312
• Product Code: OVE
• UDI-Device Identifier: M682530238140
• UDI-Public: +M682530238140/$V13/16D20160101W
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2016

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: 5302-3814
• Device Lot Number: V13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1