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

Model Number 47127

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

The explanted arsenal set screws are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event Description

During a post-op visit, radiograph showed the set screws had come off the t10 and t11.Revision surgery was conducted (b)(6) 2018.Both the t10 and t11 set screws and pedicle screws were removed and replaced.Additional screws placed at t12 and l1.The original rod was cut between l1 and l2 and a rod connector was used to connect from t10 to the l2 screw the arsenal spinal fixation system was originally implanted (b)(6) 2017 from the t10 thru s1.

Manufacturer Narrative

The set screw bottom surface is the surface that interacts with the rod to create a stable construct, therefore the wear pattern on these surface were inspected.The expected contact surface between set screw and rod after fully tightened results in two inline marks on the set screw.The explant set screws displayed a "starburst" wear pattern on the bottom surface of the set screw which is indicative of motion between rod and screw.One of the set screws displayed a more "random" wear pattern, but some of the "starburst" pattern as well indicating motion.The set screws had no significant wear or shear/deformation of the threads.No significant wear or deformation was visible on the screw bodies.Therefore, the set screw disengagement may be attributed to a non-normalized rod which caused repeated motion at the rod-screw interface resulting in set screw back out.

• 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 younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 7540229
• MDR Text Key: 109122579
• Report Number: 2027467-2018-00030
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)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,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 7987002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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): Hospitalization
• Patient Age: 63 YR