BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1941126 · Received December 29, 2010

    Report

    Report Number
    1030489-2010-01655
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CATALOG AND LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE PEDICLE SCREWS THAT WERE USED ARE CATALOG #G7643635, LOT H09D4924, EXPIRATION DATE 04/28/2017; CATALOG #G7643640, LOT H08K8968, EXPIRATION DATE 11/14/2016; CATALOG #G7643640, LOT H09B1781, EXPIRATION DATE 02/14/2017. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7643635 AND 7643640, 510K # K040583 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 7643635 IS 05/16/2008; THE MANUFACTURE DATE FOR LOT H09D4924 IS 05/04/2009; THE MANUFACTURE DATE FOR LOT H08K8968 IS 11/14/2008; THE MANUFACTURE DATE FOR LOT H09B1781 IS 02/23/2009. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE AT L1-L3 USING POSTERIOR FIXATION VIA ANTERIOR APPROACH. BECAUSE THE L1 SCREW CAME OFF, THE REVISION SURGERY WAS PERFORMED APPROXIMATELY 7 DAYS POST OP TO ADD FUSION AT T12-L3 USING POSTERIOR FIXATION. NO ANY COMPLICATION WAS REPORTED AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention ROD AND SET SCREWS