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

Model Number	ABAA00055
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3015941638-2022-00001
• Device Sequence Number: 11931389
• Product Code: NKB
• UDI-Device Identifier: 00841379131212
• UDI-Public: 00841379131212
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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 Age: 64 YR
• Patient Sex: Male