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

Model Number 47127

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 04/05/2022

Event Type  Injury  

Event Description

A patient underwent a posterior spinal fusion at l3-s1.Around 7 weeks postoperatively, a radiograph revealed a set screw had backed out of the s1 screw on the right.

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.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 14293648
• MDR Text Key: 290941715
• Report Number: 2027467-2022-00023
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: 00840967124582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214006
• 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: 04/05/2022

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
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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