BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 6408516 · Received March 15, 2017

    Report

    Report Number
    1030489-2017-00551
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 10, 2017
    Report Date
    April 3, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCTS WERE IMPLANTED INCLUDING: CATALOG# LOT # QTY 510# UDI# 7540020, UNK, 4 , K052187 , (B)(4). 75445540, UNK, 2, K042025, (B)(4). 75446545, UNK , 2, K042025, (B)(4). 8690035 , UNK, 2 , K011508 , (B)(4). ALTHOUGH IT IS UNKNOWN IF ANY OF THESE PRODUCTS CONTRIBUTED TO THE REPORTED EVENT WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES ONLY. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    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 A LUMBAR FUSION SURGERY TO TREAT A SPONDYLOLISTHESIS AT L5-S1. SURGERY WAS PERFORMED MINIMALLY INVASIVE WITH SPINAL INSTRUMENTATION. SURGERY WAS SUCCESSFUL AND PAIN LEVEL AFTER SURGERY WAS AROUND 2/10.IT WAS REPORTED THAT ON (B)(6) 2017, POST-OP, PATIENT COMPLAINED PAIN. PAIN STARTED ONE HOUR AFTER WALKING, WHEN PATIENT STARTED WIPING THE FLOOR. PAIN WAS 6/10, AND WENT TO 9/10 WHEN BENDING OVER. THE PATIENT CONSULTED A FAMILY DOCTOR AND PALPATION OF THE L5-S1 AREA WAS CORRELATED WITH THE PAIN. ALSO, FOUR SYNTHES SCREWS AND FOUR SYNTHES ATB PLATE WERE ALSO IMPLANTED. AT THIS DATE, NO FURTHER TREATMENT PERFORMED ON THE PATIENT. IT IS UNKNOWN WHETHER ANY MALFUNCTION OCCURRED WITH ANY OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190756 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other