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

Model Number	47127
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 6/4/2020 the sales representative provided additional information."the surgeon does not believe this was a hardware failure.He also informed the hospital administration of his observation".No evaluation possible at this time.The implant has not been returned.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
During a revision surgery on (b)(6) 2020 it was discovered that the left l5 set screw was loose.Additionally, the right l5 polyaxial screw was loose in the vertebral body; however the set screw on this level was not loose.The patient informed the surgeon that 6 weeks post-operative surgery she was pushing a 250 lb.Motorized wheelchair very hard up against a wall and felt a pop in her back.This is when she started to have back pain.The arsenal spinal fixation system was originally implanted on (b)(6) 2020 at the l3-l5.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 10215305
• Report Number: 2027467-2020-00029
• Device Sequence Number: 19356549
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/30/2020
• 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: 56 YR