BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6833456 · Received August 31, 2017

    Report

    Report Number
    1030489-2017-01983
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 3, 2017
    Report Date
    August 3, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    UDI-DI
    00613994966476
    PMA / PMN Number
    K113174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: TRAUMA- FRACTURE IN "LWS" AREA PROCEDURE: SUPPLY OF A TRAUMA FRACTURE IT WAS REPORTED THAT DURING SURGERY, A METAL ABRASION OCCURRED WHEN THE SET SCREW WAS SCREWED IN THE SAGITTAL ADJUSTING SCREW(SAS). NO FRAGMENT OF THE SET SCREW REMAINED IN THE PATIENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614882 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK 00613994966476

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR