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

Catalog Number	5301-3814
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is a bone screw that was implanted and explanted within the same procedure.Complainant part is expected to be returned for review/investigation, but has not been completed.A follow up report will be filed once the product has been evaluated.
Event or Problem Description
The dr was inserting the final tcs standard screw into the patient when he noticed that ht escrew was "hollowing" and making the hole larger instead of holding in place.The dr.Decided to remove the screw from the patient and with much difficulty was finally able to do so.The surgeon completed the planned procedure but he did not insert a new screw where he had removed the one which was not holding.

• Brand Name: ENDOSKELETON TCS 3.8MM DIA BONE SCREW 14MM
• Common Device Name: SPINAL BONE SCREW
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive drive; suite a; mequon WI 53092
• MDR Report Key: 7287295
• Report Number: 3006340236-2018-00007
• Device Sequence Number: 1824018
• Product Code: OVE
• UDI-Device Identifier: 00191375011422
• UDI-Public: 01001913750114221117081110V2634053013814
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: G151596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: No Information
• Device Catalogue Number: 5301-3814
• Device Lot Number: V26
• 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: 01/24/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR