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

Model Number 47127

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implant has not been removed from the patient nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

Post op x-rays revealed the set screw positioned at the l5 had become disengaged from the polyaxial screw.At this time the patient is doing well therefore the surgeon is not planning on revising.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 11576410
• MDR Text Key: 244221232
• Report Number: 2027467-2021-00013
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other