BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 7094740 · Received December 7, 2017

    Report

    Report Number
    1030489-2017-02471
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: 55711016030, LOT: UNKNOWN, QTY: 2; PRODUCT ID: 1604300500, LOT: UNKNOWN, QTY: 1; PRODUCT ID: 5530130, LOT: UNKNOWN, QTY: 1; PRODUCT ID: 55711016530, LOT: UNKNOWN, QTY: 3; PRODUCT ID: 7078397, LOT: UNKNOWN, QTY: 1). G5: THE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER LIKE DEVICES WITH (CATALOG # 55811015550, 510K# K122433, (B)(4) CATALOG # 1604200500, 510K# K113174, (B)(4) CATALOG # 5440130, 510K # K102555 AND (B)(4) CATALOG # 55811015550, 510K# K122433, (B)(4) CATALOG#: 5440130, 510K # K102555 AND (B)(4)) RESPECTIVELY WERE APPROVED FOR SALE IN UNITED STATES. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 THAT THE PATIENT UNDERWENT SPINAL CORRECTION FUSION AT TH5-7 DUE TO HEMI-VERTEBRA. POST-OPERATIVELY, INFECTION WAS SUSPECTED, AND FOLLOW-UP WAS CONTINUED. WHEN THE PATIENT VISITED THE HOSPITAL IN 2017, THE SUSPICION OF THE INFECTION FURTHER INCREASED WHICH WAS CONFIRMED IN REVISION. THEREFORE, ALL THE IMPLANTS WERE EXPLANTED IN THE REVISION SURGERY. NO PRODUCT MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877731 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention