BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03600

    MDR report key: 3180592 · Received June 20, 2013

    Report

    Report Number
    2520274-2013-03600
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    July 22, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ADDITIONAL EVALUATION REPORTS THAT ACCORDING TO THE INFORMATION ON THE RECEIVED DOCUMENTS IT HAS BEEN NOTICED THAT THE SCREWS HAD STRIPPED FROM THE VERTEBRAL BODY BONE. SINCE THE CONCERNED IMPLANTS WERE NOT RETURNED FOR ANALYSIS AND THE EXACT ARTICLE AND LOT NUMBERS ARE NOT KNOWN THE PRESENT COMPLAINT CANNOT BE FULLY ANALYSED AND WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. NEVERTHELESS, YOU MAY BE ASSURED THAT WE HAVE TAKEN NOTE OF YOUR INPUT, THIS REPORT HAS BEEN ENTERED INTO OUR MARKET VIGILANCE SYSTEM AND THE CORRESPONDING STATISTICAL DATA WILL BE KEPT UNDER TRENDING. REGRETTABLY WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT. CORRECTION DATA: UPDATED REPORT GIVEN NEW INFORMATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON REPORTED THAT A VECTRA PLATE BROKE POST OP REQUIRING A REVISION. THE INITIAL SURGERY DATE IS UNKNOWN. AS OF (B)(6) 2013, THE REVISION SURGERY DATE HAD NOT BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2013, THE PATIENT HAD TO UNDERGO A REVISION SURGERY DUE TO MALUNION OF A CAGE (UNKNOWN PART AND LOT). THIS REVISION WAS DONE WITH A SYNCAGE C AND VECTRA PLATE. A FEW WEEKS POST OPERATION, IT WAS NOTED THAT TWO SCREWS HAD STRIPPED FROM THE VERTEBRAL BODY BONE. IT IS NOT KNOWN IF ANOTHER REVISION SURGERY IS NEEDED. THIS BECAUSE THERE IS AN EXISTING HOLE WHERE, DUE TO THE CLOSER PLACEMENT OF THE VECTRA SCREWS IN COMPARISON TO THE CSLP PLATE, THE SCREWS MIGHT HAVE LESSER GRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281314 KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention