MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number 47127

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implant has not been removed from the patient nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

A patient underwent revision surgery on (b)(6) 2016 to remove & replace both the right & left set screws located at the s1 (ref.Mdr 2027467-2016-00044).Post-op x-rays taken during a scheduled visit on (b)(6) 2016 revealed the previously replaced set screws on both the right & left sides of the s1 where still in place.However, during a review of the films, it was discovered that the set screw located on left side l2 had subsequently backed out of position.The patient is currently doing fine and is asymptomatic.The surgeon is not planning to revise unless it becomes apparent that it's required at a later time.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard welch ; 5818 el camino real; carlsbad, CA 92008 ; 7604946611
• MDR Report Key: 5820227
• MDR Text Key: 51148514
• Report Number: 2027467-2016-00051
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: 00840967124582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133221
• 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: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• 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): Other