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

Model Number	47127
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Post-op x-rays revealed two arsenal set screws had backed out of position.Revision surgery was conducted on (b)(6) 2019.The arsenal spinal fixation system was originally implanted on (b)(6) 2018.
Additional 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.The tulip and set screw had no significant wear or shear/deformation of the threads.The tulip internal geometry displayed internal wear marks between rod, tulip and bushing indicating that there was motion between these components.Therefore, the set screw disengagement may be attributed to repeated motion at the rod-screw interface resulting in set screw back out.

• Brand Name: SET SCREW (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8856739
• Report Number: 2027467-2019-00039
• Device Sequence Number: 11374493
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8067901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8067901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR