MAUDE Adverse Event Report: ASTURA MEDICAL ASTURA MEDICAL; SPINAL HALF PLATE IMPLANT

Model Number	LDB000006
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The locking mechanism broke post surgery allowing the screw to begin backing out which resulted in a revision surgery to correct the problem.

• Brand Name: ASTURA MEDICAL
• Common Device Name: SPINAL HALF PLATE IMPLANT
• 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: 19479889
• Report Number: 3015941638-2024-00006
• Device Sequence Number: 11780092
• Product Code: ODP
• UDI-Device Identifier: 00840085232626
• UDI-Public: 00840085232626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/23/2024

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: LDB000006
• Device Catalogue Number: LDB000006
• Device Lot Number: 568306D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White