BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3813727 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02527
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 2991322, LOT # H12T3765; PART # 2990922, LOT # H13K0609; PART # 5440030 (X6); PART # 1475501070; PART # 1475501060; AND # 54840005540 (X6). (B)(4). MANUFACTURE DATE FOR LOT H12T3765 IS 10/04/2012; MANUFACTURE DATE FOR LOT H13K0609 IS 10/16/2013. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-4 AND L4-5 POSTERIOR LUMBAR DECOMPRESSIVE LAMINECTOMIES WITH INTERBODY FUSIONS, AND AN L5-S1 DECOMPRESSION WITH INSTRUMENTATION. THE PATIENT WAS DISCHARGED TO A ¿SKILLED NURSING FACILITY¿ FIVE DAYS POST-OP. TWO DAYS LATER THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH ¿FEVER, RIGHT-SIDED FACIAL DROOP, RIGHT SIDED WEAKNESS AND SLURRED SPEECH.¿ THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL THE FOLLOWING DAY. WOUND CULTURES GREW E. COLI. IT WAS NOTED THAT THE PATIENT¿S WBCS WERE LOW DURING BOTH HOSPITALIZATIONS. DURING THE SECOND HOSPITALIZATION, PATIENT WAS TREATED WITH MULTIPLE ANTIBIOTIC COVERAGES. FOUR DAYS FOLLOWING READMISSION, THE PATIENT WAS RETURNED TO THE OR FOR A ¿REOPENING OF THE LUMBAR WOUND, DEBRIDEMENT, PULSE LAVAGE AND PLACEMENT OF A WOUND VAC DRAIN.¿ THE PATIENT WAS BACK IN THE OR FOUR DAYS LATER FOR MORE DEBRIDEMENT AND LAVAGE. TEN DAYS LATER, THE PATIENT RETURNED TO THE OR FOR THE THIRD TIME SINCE THE ORIGINAL SURGERY AND UNDERWENT MORE DEBRIDEMENT AND LAVAGE AND A SECONDARY CLOSURE OF THE WOUND. THE WOUND WAS LAST REPORTED TO BE OOZING SERO-SANGUINOUS FLUID, BUT NO PUS. THE INCISION WAS REPORTED TO BE ¿LOOKING GOOD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291085 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization RODS, SCREWS, VB REPLACEMENT, BONE GRAFT