BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 7657805 · Received July 3, 2018

    Report

    Report Number
    1030489-2018-00943
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 9193011, LOT: NY81, QTY: 1, UDI# (B)(4), 510(K): K052261; PRODUCT ID: 75445540, LOT: UNKNOWN, QTY: 1, UDI# (B)(4), 510(K): K042025; PRODUCT ID: 75445545, LOT: UNKNOWN, QTY: 1, UDI# (B)(4), 510(K): K042025; PRODUCT ID: 7540020, LOT: UNKNOWN, QTY: 1, UDI# (B)(4), 510(K): K052187; PRODUCT ID: 8690040, LOT: UNKNOWN, QTY: 1, UDI# (B)(4), 510(K): K011508. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. H6: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PATIENT CALL THAT POST-OP, THE PATIENT HAD ALLERGIC REACTIONS TO DIFFERENT MEDICATIONS. SEVERE HYPERSENSITIVITY-WEAKNESS IN ARMS/LEGS AND PAIN IN MOST AREAS OF THE BODY WAS NOTED. THE PATIENT ALSO ALLEGED THAT THE ALLERGIC REACTION MIGHT HAVE BEEN DUE TO THE METALS IN THE IMPLANTS. IN AN ALLERGY TEST, IT WAS DETERMINED THAT THE PATIENT IS HIGHLY REACTIVE TO NICKEL AND MILDLY REACTIVE TO TWO OTHER METALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501438 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other