BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW NO LOCK D4.5X18MM

    MDR report key: 2537480 · Received April 17, 2012

    Report

    Report Number
    1818910-2012-10228
    Event Type
    Injury
    Date Received
    April 17, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A DEPUY (B)(4) SUPPLIER EXAMINED THE RETURNED PRODUCTS AND CONFIRMED THE COMPLAINT; THE CUP WAS NOT RETURNED. A DEPUY (B)(4) SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS FOR THE PROVIDED PART AND LOT CODES AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED FOR THE CUP WAS UNAVAILABLE. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED FOR TWO OF THE SCREWS WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PART AND LOT INFORMATION HAS BEEN RECEIVED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION UPON ITS COMPLETION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE. POLY WEAR WAS ALSO REPORTED.

    Description of Event or Problem · 1

    PART AND PART/LOT INFORMATION HAS BEEN RECEIVED FOR THE THREE SCREWS. THIS INFORMATION WILL NOT AFFECT THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND SCREW NO LOCK D4.5X18MM METAGLENE SCREW HSD DEPUY FRANCE 5037530

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention