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

Model Number	GCDBAZZ08
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3011764740-2023-00002
• Device Sequence Number: 20347952
• Product Code: KWQ
• UDI-Device Identifier: 00840085229312
• UDI-Public: 00840085229312
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: GCDBAZZ08
• Device Catalogue Number: N/A
• Device Lot Number: 391806B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male