BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1884061 · Received October 13, 2010

    Report

    Report Number
    1030489-2010-01325
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MNI
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BONE SCREW WAS RETURNED FOR EVAL. MACROSCOPIC EXAMINATION CONFIRMS THE BONE SCREW IS BROKEN; SIGNIFICANT FRACTURE SURFACE DAMAGE IS NOTED. MICROSCOPIC EXAMINATION REVEALS A FAIRLY FLAT FRACTURE SURFACE WITH PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A POSTERIOR LATERAL FUSION AT L5-S1. THE PROCEDURE WAS A DECOMPRESSION, LAMINECTOMY, AND FORAMINOTOMY, WITH BILATERAL FUSION WITH LOCAL BONE. THE PT UNDERWENT A REVISION SURGERY 13 MONTHS POST-OP BECAUSE THE PT HAD NOT FUSED. UPON REMOVAL OF BOTH S1 SCREWS, IT WAS FOUND THAT THE SCREWS WERE BROKEN. THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH NEW SCREWS. THE L5 SCREWS WERE LEFT IN FROM THE ORIGINAL SURGERY. NEW RODS AND SET SCREWS WERE USED IN THE PT. NO ADDITIONAL PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW MNI MEDTRONIC SOFAMOR DANEK USA, INC. NA H08G6227

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention EXPLANTED:| SET SCREW:| IMPLANTED:| ROD:| EXPLANTED:| IMPLANTED: