BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6108715 · Received November 17, 2016

    Report

    Report Number
    1030489-2016-03155
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    UDI-DI
    00681490843812
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008: PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: DEGENERATIVE DISC DISEASE, DISCOGENIC PAIN AND INSTABILITY. PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY FUSION AT L4-5, L5-S1. IMPLANTATION OF CAGES X2 AT L4-5, L5-S1. ANTERIOR PLATING L4-5, L5-S1. DISCECTOMY L4-5, L5-S1. AS PER THE OP-NOTES: &THE ANTERIOR LONGITUDINAL LIGAMENT AND ANNULUS WAS INCISED AT 4-5 AND 5-1, AND DISCECTOMIES TAKEN BACK TO THE POSTERIOR LONGITUDINAL LIGAMENT AT BOTH LEVELS. IRRIGATION WAS PERFORMED. THEN, BOTH WERE SIZED TO 20 MM, AND BEGINNING AT THE 5-1, THE 20 MM DISTRACTOR WAS INSERTED AND THE DISC SPACE WAS REAMED TO 32 MM OF DEPTH BY 20 MM HEIGHT ON THE LEFT AND RIGHT AND TWO 20 MM CAGES WERE PACKED WITH RHBMP-2/ACS WERE PUT INTO THE PLACE. THIS WAS REPEATED AT 4-5 WITH 20 MM CAGES INSERTED THERE. IMPLANTS WERE STABLE AND THE PATIENT TOLERATED THE PROCEDURE WELL. & PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761307 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110610AAK 00681490843812

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other