BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6649407 · Received June 19, 2017

    Report

    Report Number
    1030489-2017-01560
    Event Type
    Injury
    Date Received
    June 19, 2017
    Report Date
    May 22, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    UDI-DI
    00681490843782
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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.

    Additional Manufacturer Narrative · 1

    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) 2009, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: ANNULAR TEAR, DISCOGENIC BACK PAIN; L5-S1 AND DEGENERATIVE LUMBAR DISC DISEASE; L5-S1. PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR RETROPERITONEAL EXPOSURE. ANTERIOR LUMBAR FUSION L5-S1. ANTERIOR LUMBAR INSTRUMENTATION USING THE SPINAL USA ¿ ANTERIOR PLATING SYSTEM. INSERTION OF INTERBODY FUSION CAGE USING THE SPINAL USA- PEEK INTERBODY CAGE. USE OF FLUOROSCOPY UNDER PHYSICAL SUPERVISION FOR LESS THAN 1 HOUR. AS PER OP-NOTES: ¿ THE SPINAL USA ¿PEEK INTERBODY CAGE WAS THEN PACKED WITH RHBMP-2/ACS AND CANCELLOUS ALLOGRAFT. THE CAGE WAS THEN INSERTED INTO THE DISC SPACE WITHOUT DIFFICULTY. A NICE SNUG FIT WAS OBTAINED.¿ EXCELLENT FIT OF THE INSTRUMENTATION WAS OBTAINED. PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. POST-OP, THE PATIENT ALLEGED UNSPECIFIED INJURY DUE TO USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430609 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110803AAJ 00681490843782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other