MAUDE Adverse Event Report: SPINEOLOGY INC. GRAFT TUBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	312-0056
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient underwent an interbody fusion procedure on (b)(6) 2024.During the surgical procedure, mallet impact forces were applied to deploy bone graft material through the graft tube instrument causing the graft tube shaft to detach from the graft tube funnel head.Upon further impaction, the shaft component inadvertently advanced ventral to the anterior annulus.The shaft component was retrieved and the surgeon confirmed no patient injury or consequence.

• Brand Name: GRAFT TUBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 20081190
• Report Number: 2135156-2024-00015
• Device Sequence Number: 18064339
• Product Code: LXH
• UDI-Device Identifier: M7403120056
• UDI-Public: M7403120056
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 312-0056
• Device Lot Number: CH20003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female