MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON® TAS; BONE SCREW

Catalog Number	2300-6530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the surgeon felt the subject device length was too long while implanting.When removed, the customer noticed the screw threads were delaminated.The surgeon completed the case successfully using a shorter screw with no further incident.There was no case delay and no patient pain or injury reported.The device history record for the subject device was reviewed.The device was conforming to all quality specifications upon initial release.Engineering technical review confirmed the damage to the screw threads, and noted the most likely cause to be contact between the screw thread and the screw bores on the cage due to the angle of screw insertion.The device is single-use and will be scrapped to prevent use.
Event or Problem Description
It was reported that the surgeon was implanting the screw and felt the length was too long, so they decided to utilize a smaller screw size.Upon removal of the initial screw, they noticed the screw threading was stripped in places.

• Brand Name: ENDOSKELETON® TAS
• Common Device Name: BONE SCREW
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• MDR Report Key: 8241863
• Report Number: 3006340236-2019-00002
• Device Sequence Number: 13848512
• Product Code: OVD
• UDI-Device Identifier: 00191375001874
• UDI-Public: 00191375001874
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2300-6530
• Device Lot Number: H4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/11/2019
• 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
• Patient Age: 52 YR