MAUDE Adverse Event Report: ASTURA MEDICAL CORTICAL POLYAXIAL SCREW, CANNULATED 8.5MM X 55MM

Model Number	AARA85055
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
A screw broke while implanted.(post-op).

• Brand Name: CORTICAL POLYAXIAL SCREW, CANNULATED 8.5MM X 55MM
• Common Device Name: POLYAXIAL SCREW
• Manufacturer (Section D): ASTURA MEDICAL; 4949 w royal ln.; irving TX 75063
• Manufacturer Contact: parker kelch ; 4949 w royal ln; irving, TX 75063 ; 4695015530
• MDR Report Key: 18847516
• Report Number: 3015941638-2024-00004
• Device Sequence Number: 20758783
• Product Code: OSH
• UDI-Device Identifier: 00841379161219
• UDI-Public: 00841379161219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153446N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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: AARA85055
• Device Catalogue Number: AARA85055
• Device Lot Number: 212313C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/06/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic
• Patient Race: White