BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 3190324 · Received June 26, 2013

    Report

    Report Number
    2246640-2013-00017
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOUND THAT THE DEVICE WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. DETAILS AND TIMELINE REPORTED INDICATE THAT THE DEVICE PERFORMED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF), THE SURGEON HARVESTED AN AUTOGRAFT BONE WEDGE FROM THE PATIENT¿S ILIAC CREST, AND FILLED THE REMAINING DEFECT WITH RESORBABLE BONE VOID FILLER. APPROXIMATELY 8 WEEKS POST-OP, THE PATIENT WAS REPORTEDLY EXPERIENCING ¿EXCESSIVE SWELLING AND DRAINAGE,¿ ¿PAIN AT THE GRAFT SITE¿, A ¿FLUID FILLED POCKET¿ AT THE GRAFT SITE, AS WELL AS ¿NON-UNION¿IN THE GRAFT SITE.¿ THE PATIENT REPORTEDLY UNDERWENT A REVISION PROCEDURE TO EXPLANT, IRRIGATE AND DRAIN THE SITE ¿OF ANY EXCESS FLUID,¿ AND A CORAL BLOCK WAS INSERTED INTO THE ILIAC CREST DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290780 PLEXUR M FILLER, BONE VOID, CALCIUM COMPOUND MQV OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) 6100-010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R