BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3013750 · Received March 20, 2013

    Report

    Report Number
    1030489-2013-00817
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    June 19, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    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 THE PATIENT UNDERWENT UNSPECIFIED SPINAL FUSION SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "PROBLEMS INCLUDING PAIN, IT HAS REQUIRED [PATIENT] TO FOLLOW UP WITH DOCTOR FREQUENTLY. IT ALSO GAVE [PATIENT] CANCER. [PATIENT] WORRIED [PATIENT] WILL NEVER BE WELL AGAIN."

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: LUMBAR SPONDYLOLISTHESIS, CONGENITAL. SEGMENTAL INSTABILITY L4-L5, SECONDARY TO GRADE 1 SPONDYLOLISTHESIS AND L5-S1 ANNULAR TEAR. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL L4-L5 LAMINECTOMY, FORAMINOTOMY AND FACETECTOMY THROUGH GILL PROCEDURE. BILATERAL L4-L5 RADICAL DISCECTOMY AND ANTERIOR BODY FUSION USING CAGES AND BONE MORPHOGENIC PROTEIN GRAFT SUBSTITUTE. BILATERAL L4-L5 AND L5-S1 ARTHRODESIS USING POSTEROLATERAL TECHNIQUE AND MORCELLIZED AUTOGRAFT AND ALLOGRAFT AND BMP. BILATERAL L4-S1 PEDICLE SCREW FIXATION AND ARTHRODESIS. LUMBAR 4-5 DISKECTOMY, INTERBODY FUSION AND LUMBAR 4-SACRAL 1 PEDICLE SCREW FUSION WITH BONE MORPHOGENIC PROTEIN. AS PER OPERATIVE NOTES, ¿A 10-MM HEIGHT BONE SUBSTITUTE WERE THEN USED, THOSE WERE PREPACKED WITH BONE MORPHOGENIC PROTEIN AND IMPREGNATED SPONGE AND INSERTED IN THE DISC SPACE AGAIN AT L4-L5 BILATERALLY AND COUNTERSUNK ABOUT FEW MILLIMETER TO ENSURE NO DIFFICULTY WITH THE BONE FORMATION. MORSELLIZED AUTOGRAFT, ALLOGRAFT AND BONE MORPHOGENIC PROTEIN AUTOGRAFT SUBSTITUTE WAS THEN USED TO LAY ON THE TRANSVERSE PROCESSES AT L4-L5 AND SACRAL ALA.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116842 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention