MAUDE Adverse Event Report: SPINEOLOGY INC. PALISADE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	670-5535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an instrumented lumbar interbody fusion with placement of palisade screws without incident.Approximately 10 months post-operative, it was observed that one of the screws was broken.A revision surgery was conducted to remove and replace all four screws in the construct.
Additional Manufacturer Narrative
The information contained in this report is being provided to the fda to comply with medical device reporting regulations and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination of admission that a device has malfunctioned or that a device is related to an injury or death.Pursuant to manufacturer policy, events resulting in a revision surgery are deemed a serious injury as defined in 21 cfr 803.3 and are determined to be mdr reportable events.

• Brand Name: PALISADE
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; saint paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; saint paul MN 55128 5455
• Manufacturer Contact: megan polos ; 7800 3rd street n.; suite 600; saint paul, MN 55128-5455 ; 6512568500
• MDR Report Key: 19712682
• Report Number: 2135156-2024-00009
• Device Sequence Number: 20967746
• Product Code: NKB
• UDI-Device Identifier: M7406705535
• UDI-Public: M7406705535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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 Catalogue Number: 670-5535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 36 YR
• Patient Sex: Female