MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARSENAL SPINAL FIXATION SYSTEM; PEDICLE SCREW SYSTEM

Model Number	47127
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The initial surgery took place on (b)(6) 2020.Four (4) months after the surgery, loosening of the l3 right set screw was found.Revision surgery to replace the set screw took place on (b)(6) 2021.During the surgery, l4/l5 screw were also found loosened and the surgeon re-tightened them.
Additional Manufacturer Narrative
Review of the device history records did not identify any manufacturing or processing related irregularities.Investigation of the set screw showed that the threads are not deformed which indicates that set screw was not cross threaded.The bottom surface of the set screw was examined for wear patterns created against the construct rod during final set screw tightening.The expectation for the bottom surface of a set screw installed in a stable construct is a symmetric hour glass pattern.None of the three (3) screws examined demonstrated the expected hour-glass pattern: based on these findings, the anterior wear marks on the set screws indicate the set screw disengagement is a result of a nondistributed loading and non-normalized rod conditions at final lockdown.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11809152
• Report Number: 2027467-2021-00026
• Device Sequence Number: 19810595
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8185401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: No Information
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8185401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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