BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK ANATOMIC PEEK STRUT

    MDR report key: 5267393 · Received December 1, 2015

    Report

    Report Number
    MW5058282
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    May 11, 2009
    Report Date
    December 1, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2009, PT UNDER C5 CORPECTOMY UTILIZING VERTE-STACK ANATOMIC PEEK ((B)(4)), TWO 11X14 X 8MM END CAPS PART #6240841 JOINED BY CENTER STRUT 11X14X5MM PART #6241041 FORMING A 21MM (H) BY 11X14MM (L)X(D) CERVICAL CORPECTOMY CONSTRUCT. THE CERVICAL CORPECTOMY CONSTRUCT WAS PACKED WITH RHBMP-2/SPONGE COMPONENT OF THE INFUSE BONE GRAFT ((B)(4)). PT DEVELOPED PROGRESSIVE BI-LATERAL PARESIS BOTH UPPER EXTREMITIES AND HANDS, INCONTINENCE, GAIT, DYSPHONIA, DYSPHAGIA. POSTERIOR LAMINECTOMY REVISION WAS PERFORMED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790100 VERTE-STACK ANATOMIC PEEK STRUT VERTE-STACK ANATOMIC PEEK STRUT MQP MEDTRONIC 6241041 PU75
    790101 VERTE-STACK ANATOMIC PEEK STRUT VERTE-STACK ANATOMIC PEEK STRUT CAP MQP MEDTRONIC 6240841
    790102 VERTE-STACK ANATOMIC PEEK STRUT VERTE-STACK ANATOMIC PEEK STRUT CAP MQP MEDTRONIC 6240841
    790304 INFUSE BONE GRAFT NEK MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R| S