MAUDE Adverse Event Report: TITAN SPINE LLC ENDOSKELETON® TCS BONE SCREW, LOCKING, 3.8X14MM

Catalog Number 5302-3814

Device Problem Entrapment of Device (1212)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.It was confirmed that the device malfunctioned as reported.It is likely that the device interacted with the implant body unfavorably causing the locking collar to become disassociated.

Event Description

It was reported that the locking collar became disassociated from the screw body during the surgical procedure.

• Brand Name: ENDOSKELETON® TCS BONE SCREW, LOCKING, 3.8X14MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): TITAN SPINE LLC; 6140 w. executive dr., ste a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE LLC; 6140 w. executive dr., ste. a; mequon WI 53092
• Manufacturer Contact: kelly mcdonell ; 6140 w. executive dr., ste. a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7436134
• MDR Text Key: 105762116
• Report Number: 3006340236-2018-00014
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5302-3814
• Device Lot Number: V26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 63 YR