BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORT. SCREW 5.5MMX 55MM

    MDR report key: 1090525 · Received July 30, 2008

    Report

    Report Number
    1818910-2008-03274
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K972183
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH REPORTED PART AND LOT NUMBER COMBINATIONS. THE PART AND LOT NUMBERS FOR THE SCREWS WERE NOT PROVIDED. PROVIDED INFO STATES THE PT REQUESTED REMOVAL OF THE NAIL BECAUSE OF PAIN. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCTS AND/OR 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 REQUESTED REMOVAL OF TIBIAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORT. SCREW 5.5MMX 55MM 87HSB HSB DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention