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

Model Number ABAA00055

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

Patient had a spinal fusion surgery performed on (b)(6) 2020.During a follow-up it was observed that some of the locking set screws had become dislodged from the pedicle screws.A revision surgery was performed to replace the locking screws.No injury to the patient as a result of the event.

Manufacturer Narrative

This event was originally reported on (b)(6) 2020.Our initial investigation led to the conclusion that a mdr was not warranted.However, after a 3rd party audit of our quality system it was identified that this event is should be reported due to the surgical intervention that was performed.A capa was created to review our investigation process and update the relevant sop documents.Older feedback investigations were reviewed to determine if any warrant a mdr.In response to the audit and capa, this mdr is being submitted retroactivly per our updated guidelines.

• Brand Name: OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• 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: 14310089
• MDR Text Key: 295153770
• Report Number: 3015941638-2022-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00841379131212
• UDI-Public: 00841379131212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ABAA00055
• Device Catalogue Number: ABAA00055
• Device Lot Number: 421101G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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
• Patient Age: 64 YR
• Patient Sex: Male