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

Model Number	47127
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records did not identify any manufacturing or processing relate irregularities.The set screw was found to be properly manufactured and released in accordance with design specifications.
Event or Problem Description
On (b)(6) 2021 it was found the set screw in the pedicle screw implanted at l4 was loosened and the rod came out of the tulip of the screw post surgery.A revision surgery was conducted on (b)(6) 2021 to remove and replace the construct.The arsenal spinal fixation system was implanted on (b)(6) 2021.

• 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: 11682737
• Report Number: 2027467-2021-00016
• Device Sequence Number: 3128659
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8185401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• 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: Required Intervention
• Patient Age: 41 YR