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

Model Number	47127
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted arsenal construct is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Approximately two weeks after implantation, a patient returned complaining of pain on the right side.X-rays taken at the time identified a backed out set screw at the l5.Revision surgery was conducted on (b)(6) 2018 to remove the hardware located on the right side.Replacement was not installed.The patient no longer has pain/symptoms.The arsenal spinal fixation system was originally implanted on (b)(6) 2018.
Additional Manufacturer Narrative
An evaluation of the returned construct found the markings on the set screw indicate that the rod was not fully seated prior to conducting the final tightening/locking down process.The non-normal condition may result in a non-adequately fixed construct.The markings on the rod indicate that the set screw slid along the rod which may be the result of the set screw not being fully locked in the first place.

• 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: 7990517
• Report Number: 2027467-2018-00074
• Device Sequence Number: 11206034
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8043001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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: 66 YR