BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE PACK

    MDR report key: 14220118 · Received April 27, 2022

    Report

    Report Number
    1423395-2022-00016
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 27, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE NEURO STRIPS WERE BEING USED AND ONCE THEY BECAME SATURATED, THEY BEGAN TO FLAKE OFF INSIDE OF THE PATIENT. THE SURGEON WOULD REMOVE THE MATERIAL FROM THE PATIENT WITH FORCEPS, IRRIGATION OR SUCTION. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE, NO EFFECT ON THE PATIENT'S STABILITY, AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INCIDENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT, OR THE PROCEDURE BEING PERFORMED. THE SAMPLES WERE RETURNED TO THE MANUFACTURER AND THE CUSTOMER REPORTED ISSUE OF FLAKING MATERIAL WAS CONFIRMED HOWEVER NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE NEURO STRIPS WERE BEING USED AND ONCE THEY BECAME SATURATED, THEY BEGAN TO FLAKE OFF INSIDE OF THE PATIENT. THE SURGEON WOULD REMOVE THE MATERIAL WITH FORCEPS, IRRIGATION OR SUCTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365895 SPINE PACK SPINE PACK OJH MEDLINE INDUSTRIES LP 21LBL398

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention