BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATN LAG SCREW 115MM STERILE

    MDR report key: 1770291 · Received July 21, 2010

    Report

    Report Number
    1818910-2010-04794
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K042325
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. REVIEW OF THE AS400 SYSTEM SHOW THAT AT LEAST 10 OTHER DEVICES FROM BOTH REPORTED LOTS HAVE BEEN DELIVERED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATN LAG SCREW 115MM STERILE 87HSB HSB DEPUY ACE S.A. 'R.L. NA DFGBPB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention