MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON TCS; SCREW

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

It was reported that there was a revision surgery on a tcs screw which had backed out.No patient pain or injury was communicated on the initial report.Titan spine has sought further information into the event through multiple sources.Limited response related to the reported subject device issue has occurred.The investigation is ongoing with "his" record serving as the initial report.When further information is obtained, a follow-up report will be submitted with further detail into the event which occurred.

Event Description

It was reported that there was a revision completed on a tcs screw that had backed out.

• Brand Name: ENDOSKELETON TCS
• Type of Device: SCREW
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• Manufacturer Contact: quinn lyster ; 6140 w. executive dr.; suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 8160268
• MDR Text Key: 130212914
• Report Number: 3006340236-2018-00032
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention