BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT28IDX48OD

    MDR report key: 1983415 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01213
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING UNUSUAL OR OUTWARD TO SUGGEST PRODUCT ERROR. PER THE INITIAL REPORTING PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT28IDX48OD 87KWA KWA DEPUY INTL LTD NA 2125125

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention