MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TCS BONE SCREW LOCKING, 3.5X14MM

Catalog Number	5302-3514
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device indicated that there were witness marks on the device suggesting that an attempt had been made at implanting them.The witness marks indicate that the awl guide was not used as required in the surgical technique and the collar became disassociated due to interaction between the implant body and the collar at too steep of an insertion angle.A review of the dhr shows no issues were detected in the manufacture of the devices or failure to meet engineering specifications.The device was reported to not have been used in the subject surgical procedure, so the malfunction did not cause injury to the patient.It had been used as suggested by the marking on the implant, all pieces were retrieved.
Event or Problem Description
The locking collar disassociated from the screw without being used in the subject surgical procedure.

• Brand Name: ENDOSKELETON TCS BONE SCREW LOCKING, 3.5X14MM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive drive; suite a; mequon WI 53092
• MDR Report Key: 7366845
• Report Number: 3006340236-2018-00011
• Device Sequence Number: 16638247
• Product Code: OVE
• UDI-Device Identifier: 00191375011507
• UDI-Public: 01001913750115071117082510V2624053023514
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: V26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR