BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC IMPLANT

    MDR report key: 2313282 · Received October 28, 2011

    Report

    Report Number
    1030489-2011-01394
    Event Type
    Injury
    Date Received
    October 28, 2011
    Report Date
    September 29, 2011
    Manufacturer
    MEDTRONIC SPINAL AND BIOLOGICS
    Product Code
    MQP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT OR APPLICABLE IMAGING STUDIES HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(4) IN A PUBLICATION ENTITLED 'REVISION RATES FOLLOWING PRIMARY ADULT SPINAL DEFORMITY SURGERY: SIX HUNDRED FORTY-THREE CONSECUTIVE PATIENTS FOLLOWED-UP TO TWENTY 'TWO YEARS POSTOPERATIVE' (THE SPINE JOURNAL 35 (2010) 219-226) THAT 58 PATIENTS (9.0%) REQUIRED AT LEAST 1 REVISION. FIFTY OF 643 (2.3%) REQUIRED MORE THAN 1 PROCEDURE. THE MEAN TIME TO REVISION WAS 4.0 YEARS. IT WAS REPORTED THAT 24 PATIENTS EXPERIENCED PSEUDARTHROSIS WHICH RESULTED IN AN UNANTICIPATED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDTRONIC IMPLANT MQP MEDTRONIC SPINAL AND BIOLOGICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention