BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 6903211 · Received September 29, 2017

    Report

    Report Number
    1030489-2017-02134
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 20, 2017
    Report Date
    August 30, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PRODUCTS WERE IMPLANTED INCLUDING: CATALOG#: 1476300500, LOT #:0355001W, QTY: 1; 1476300500, 0396938W, 1; 2991226, H10F3502, 1; 4021522, ZP08, 1; 5430230, H13G0735, 2; 5430230, H5079464, 3; 5430230, H5079615, 5; 5432136, 0360121W, 1; 5432138 , 0420175W, 1; 54740007560, H11E2821, 1; 54740008540, H13G3974, 1; 54740008545, H5196843, 3; 54740008570, H5170167, 1; 54740008580, H5164186, 2; 54790015535, H5199799, 1; 54790015540, H13T1211, 2; 54790015540, H5231912, 3; 54790016540, H5283532, 4; 7068396, H5210934, 1; 7068396, H5228166, 1; 9391623, UM13E090, 1; G905H103, 0280211W, 1; GX811H300, 0425254W, 4. IT IS UNKNOWN WHICH DEVICE CONTRIBUTED TO THE REPORTED EVENT. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THERE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT T10-S2AI: POSTERIOR FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S AND VERTEBRAL COLUMN RESECTION AT L1. ON AN UNKNOWN DATE POST-OP, PATIENT DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS DUE TO FRACTURE OF T10. SO, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 TO EXTEND THE FIXATION RANGE TO T2-LOWER LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684688 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention