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

Model Number	ABAA00055
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Three set screws backed out requiring a revision surgery.

• 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 ln.; irving TX 75063
• Manufacturer Contact: parker kelch ; 4949 w. royal ln.; irving, TX 75063 ; 4695015530
• MDR Report Key: 18676594
• Report Number: 3015941638-2024-00001
• Device Sequence Number: 6195524
• Product Code: OSH
• UDI-Device Identifier: 00841379131212
• UDI-Public: 00841379131212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 02/08/2024

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: ABAA00055
• Device Catalogue Number: ABAA00055
• Device Lot Number: 684907H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AADA65055 CORTICAL POLYAXIAL SCREW 6.5MM X 55MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White