MAUDE Adverse Event Report: ASTURA MEDICAL ASTURA; PLATE

Model Number	LDD000006
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A foreign part appeared on the ct scan.A revision surgery reportedly found "a wire" which was presumbaly caused by some sheered threading from the screw.The actual implants were not returned.

• Brand Name: ASTURA
• Common Device Name: PLATE
• Manufacturer (Section D): ASTURA MEDICAL; 4949 w. royal lane; irving TX 75063
• Manufacturer (Section G): .ASTURA MEDICAL; 4949 w. royal lane; irving TX 75063
• Manufacturer Contact: parker kelch ; 4949 w. royal lane; irving, TX 75063 ; 4695011553
• MDR Report Key: 21608455
• Report Number: 3015941638-2025-00003
• Device Sequence Number: 13128290
• Product Code: OVE
• UDI-Device Identifier: 00840085250705
• UDI-Public: 00840085250705
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K202065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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
• Device Model Number: LDD000006
• Device Catalogue Number: LDD000006
• Device Lot Number: 620402A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/14/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic