BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 7444970 · Received April 19, 2018

    Report

    Report Number
    1030489-2018-00572
    Event Type
    Injury
    Date Received
    April 19, 2018
    Report Date
    April 19, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00885074502397
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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. MULTIPLE PRODUCTS WERE REPORTED BUT IT IS UNKNOWN WHICH CAUSED THE REPORTED EVENT. PRODUCT , LOT , QUANTITY , UDI , 510K. 7893035 , W08F1798, 2 , (B)(4), K052609; 7896545 , 950828 , 4 , (B)(4), K050809. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION IT WAS REPORTED THAT POST-OP, PATIENT COMPLAINS OF LOW BACK PAIN WITH BILATERAL EXTREMITY PAIN. TREATMENT INCLUDED TRIGGER POINT INJECTION OF THE SUPERIOR POSTERIOR ILIAC CREST ON RIGHT. INJECTION CONTAINED 4 CC LIDOCAINE AND 1 CC DEPO MEDROL. PROBABLE RELATIONSHIP TO INTERBODY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285152 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 3120866 00885074502397

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other