MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARSENAL SPINAL FIXATION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	47127
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The set screw remains in the patient.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.A radiograph image was provided and confirmed the event.If additional information is received, a supplemental report will be filed accordingly.
Event or Problem Description
A patient underwent a posterior spinal procedure.At the two-week postoperative visit, a radiograph image revealed a set screw completely detached from the tulip head.There are no plans for revision surgery.The surgeon will continue to monitor the patient to ensure the set screw does not migrate.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92208
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesely channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 19234077
• Report Number: 2027467-2024-00046
• Device Sequence Number: 6015596
• Product Code: KWP
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K152968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male