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

Model Number ABBA00000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/26/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 322534825
• Report Number: 3011764740-2023-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00841379176688
• UDI-Public: 00841379176688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ABBA00000
• Device Lot Number: 635601A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention