MAUDE Adverse Event Report: ASTURA MEDICAL OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICALE SCREW SYSTEM

Model Number	ABBA00000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The locking set screws for the olympic posterior spinal fixation screw system backed out of the inserted pedicle screws in the patient.This was discovered during a post-op x-ray and a revision surgery was performed to replace the removed set screws.

• Brand Name: OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICALE SCREW SYSTEM
• 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: 17672673
• Report Number: 3011764740-2023-00001
• Device Sequence Number: 5981303
• Product Code: NKB
• UDI-Device Identifier: 00841379176688
• UDI-Public: 00841379176688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182239
• 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: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: ABBA00000
• Device Lot Number: 635601A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown