MAUDE Adverse Event Report: ASTURA MEDICAL ASTURA MEDICAL; SET SCREW

Model Number	NCAA00000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Set screws popped out causing a revision surgery.
Additional Manufacturer Narrative
Items from the same lot were tested and work as they should.Original receiving inspection reports show implants to be in specification.Torque handles were tested and within operational calibration range.

• Brand Name: ASTURA MEDICAL
• Common Device Name: SET SCREW
• Manufacturer (Section D): ASTURA MEDICAL; 4949 w. royal ln; irving TX 75063
• Manufacturer (Section G): ASTURA MEDICAL; 4949 w.royal lane; irving TX 75263
• Manufacturer Contact: parker kelch ; 4949 w. royal lane; irving, TX 75063 ; 4695015530
• MDR Report Key: 22287441
• Report Number: 3015941638-2025-00005
• Device Sequence Number: 8551376
• Product Code: NKB
• UDI-Device Identifier: 00840085257636
• UDI-Public: 00840085257636
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K231694
• 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
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: NCAA00000
• Device Catalogue Number: NCAA00000
• Device Lot Number: 715601B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/18/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White