MAUDE Adverse Event Report: ASTURA MEDICAL SIRION 2-HOLE LATERAL PLATE; SPINAL FIXATION

Model Number GCDBAZZ08

Device Problem Material Integrity Problem (2978)

Patient Problem Implant Pain (4561)

Event Date 06/30/2023

Event Type  Injury  

Event Description

The locking mechanism for a sirion 2-hole lateral plate separated on the superior screw allowing the screw to partially back out.This required a revision surgery to correct.

• Brand Name: SIRION 2-HOLE LATERAL PLATE
• Type of Device: SPINAL FIXATION
• Manufacturer (Section D): ASTURA MEDICAL; 4949 royal ln; irving TX 75063
• Manufacturer (Section G): ASTURA MEDICAL; 4949 royal ln; irving TX 75063
• Manufacturer Contact: parker kelch ; 4949 royal ln; irving, TX 75063 ; 4695015530
• MDR Report Key: 17672733
• MDR Text Key: 322538594
• Report Number: 3011764740-2023-00002
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00840085229312
• UDI-Public: 00840085229312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GCDBAZZ08
• Device Catalogue Number: N/A
• Device Lot Number: 391806B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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): Required Intervention
• Patient Sex: Male