BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5440513 · Received February 17, 2016

    Report

    Report Number
    1030489-2016-00491
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 8, 2016
    Report Date
    May 4, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    MULTIPLE PRODUCTS WERE IMPLANTED -UNKNOWN RHBMP-2/ACS, UNKNOWN BONE GRAFT MATIRX, (PROD. ID/LOT NO./QTY)- (2922245/XD29/1); (2152212/92AH/1); (2922250/YZ25/1); (2922245/38AG/1) IT IS UNKNOWN WHICH PRODUCT CAUSED THE ADVERSE EVENT. WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSE. (B)(4). 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.

    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) 2016, THE PATIENT UNDERWENT AN INTERBODY FUSION + ANTERIOR INSTRUMENTATION (L2-S1) . APPROXIMATELY THREE MONTHS POSTOPERATIVELY,THE PATIENT REPORTED A DIAGNOSIS OF RIGHT LEG DVT BY INTERNAL PHYSICIAN. THE PATIENT REPORTED SHE WAS NOT HOSPITALIZED FOR THIS EVENT. THE INVESTIGATOR NOTED THE EVENT WAS NOT RELATED.

    Description of Event or Problem · 1

    INITIAL DIAGNOSIS: SPINAL STENOSIS L4-L5: LEFT LATERAL RECESS, LEFT FORAMINAL, RIGHT LATERAL RECESS, RIGHT FORAMINAL L5-S1: LEFT LATERAL RECESS, LEFT FORAMINAL, RIGHT LATERAL RECESS, RIGHT FORAMINAL MECHANICAL INSTABILITY L2-L3, L3-L4, L4-L5, L5-S1 MULTILEVEL DISCOPATHIES L2-S1 IT WAS REPORTED THAT ON: ON (B)(6) 2015: PATIENT PRESENTED WITH NEUROLOGICAL DISORDER: RADICULOPATHY. THE PATIENT ALSO HAD PAIN WITH A SCORE OF 4. ON (B)(6) 2016 THE PATIENT UNDERWENT ANTERIOR AND POSTERIOR INSTRUMENTATION AT L2-S1. ONE CAGE WAS IMPLANTED AT LEVELS L2-L3; L3-4; L4-5 AND ONE CAGE WAS IMPLANTED AT L5-S1. ON (B)(6) 2016 POST-OP, THE PATIENT REPORTED AN ILEUS. THE PATIENT WAS HOSPITALIZED FOR EIGHT DAYS. THE EVENT WAS REPORTED AS NOT RELATED. THE OUTCOME OF THIS EVENT WAS RESOLVED WITHOUT SEQUELA. WOUND INFECTION WAS LOCATED AT THE POSTERIOR LUMBAR, CENTRAL INCISION L2-S1. APPROXIMATELY SEVENTEEN (17) DAYS POSTOPERATIVELY, THE SUBJECT WAS REPORTED TO HAVE A DEEP WOUND INFECTION. THE SUBJECT WAS ADMITTED TO THE HOSPITAL (B)(6) 2016. SITE REPORTS ¿PICC LINE IN PLACE, INTRA-OP CX + ENTEROBACTER CLOACAE ON LEVOQUIN, VAC IN PLACE.¿ THE EVENT WAS REPORTED AS NOT RELATED. THE OUTCOME OF THIS EVENT IS PENDING. APPROXIMATELY THIRTY DAYS (30 DAYS POSTOPERATIVELY), THE SUBJECT REPORTED A LEFT LEG DVT. THE SUBJECT WAS HOSPITALIZED. ON (B)(6) 2016: PATIENT UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION AND RHBMP-2, BONE GRAFT MATIRX WAS USED. ON (B)(6) 2016: THE PATIENT PRESENTED WITH FEVER, NAUSEA, VOMITING AND ABDOMINAL DISTENTION. THE PATIENT PRESENTED WITH GASTRO-INTESTINAL. ON (B)(6) 2016: THE PATIENT PRESENTED WITH DEEP WOUND INFECTION. THE WOUND INFECTION WAS LOCATED AT POSTERIOR LUMBAR. ON (B)(6) 2016, PATIENT PRESENTED WITH LEFT LEG SWELLING AND PAIN. MUSCULOSKELETAL EXAMINATION: SOME TENDERNESS TO PALPATION ON THE LEFT THIGH. PATIENT UNDERWENT VENOUS COLOR DOPPLER ULTRASOUND, LEFT LOWER EXTREMITY. IMPRESSION: NON OCCLUSIVE THROMBUS WITHIN THE LEFT COMMON FEMORAL VEIN. ON (B)(6) 2016: PATIENT UNDERWENT A TREATMENT WITH DIAGNOSIS: DVT, LEFT LEG ONGOING PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97274 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 00067 YR Other