BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SNP SCREW

    MDR report key: 2052679 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-05931
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE. PROVIDED INFO STATES THE SUPERIOR LATERAL SCREW WAS REMOVED BECAUSE IT APPEARED TO BE TOO LONG. THE INVESTIGATION COULD NOT DRAW OTHER CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO 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 ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS BACKOUT OF THE INFERIOR LATERAL SCREW, AND THE SUPERIOR LATERAL SCREW WAS ALSO REMOVED BECAUSE IT APPEARED TO BE TOO LONG. THE SNP REMAINED IN, AS WELL AS THE OTHER SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SNP SCREW TRAUMA DEVICE HWC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention