BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10137180 · Received June 10, 2020

    Report

    Report Number
    1030489-2020-00591
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 10, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER:BURN. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# 1554200500; LOT# UNK; 510K# K113174; UDI# (B)(4); QTY# 2 PART# 5540030; LOT# UNK; 510K# K113174; UDI# (B)(4); QTY# 15 PART# 55840027545T; LOT# UNK; 510K# K152604; UDI# (B)(4); QTY# 2 PART# 779145555; LOT# UNK; 510K# K101074; UDI# (B)(4); QTY# 8 PART# 779170005; LOT# UNK; 510K# K101074; UDI# (B)(4); QTY# 16 PART# 811-321; LOT# UNK; 510K# K981676; UDI# (B)(4); QTY# 1 PART# 55840024545T; LOT# UNK; 510K# K152604; UDI# (B)(4); QTY# 1. IT IS UNKNOWN WHICH OF THE ABOVE IMPLANTS WERE RESPONSIBLE FOR THE ADVERSE EVENTS. ALSO, IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT. 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 POST-OPERATIVELY, PATIENT HAS A SOLERA SYSTEM WITH CROMALOY RODS IMPLANTED. THE PATIENT EXPERIENCE A BURNING FEELING AFTER AN MRI. AS A RESULT THE HOSPITAL HAS PUT A STOP TO ALL MRI¿S ON PATIENTS WITH SOLERA IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603750 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other