MAUDE Adverse Event Report: ASTURA MEDICAL ASTURA MEDICAL; ACP, 1 LEVEL, 14MM

Model Number	CA1000014
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Screw backed out of plate requiring a revision surgery.Astura was not notified of this until (b)(6) 2025.
Additional Manufacturer Narrative
Performance testing of the implants show they meet our established performance requirements.

• Brand Name: ASTURA MEDICAL
• Common Device Name: ACP, 1 LEVEL, 14MM
• Manufacturer (Section D): ASTURA MEDICAL; 4949 w. royal ln.; irving TX 75063
• Manufacturer (Section G): ASTURA MEDICAL; 4949 w. royal ln.; irving TX 75063
• Manufacturer Contact: parker kelch ; 4949 w. royal ln.; irving, TX 75063 ; 4695015530
• MDR Report Key: 23295465
• Report Number: 3015941638-2025-00011
• Device Sequence Number: 15959443
• Product Code: KWO
• UDI-Device Identifier: 00841379102380
• UDI-Public: 00841379102380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: CA1000014
• Device Catalogue Number: CA1000014
• Device Lot Number: 765801F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White