BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBI CHSP 6SL 140MM 130D

    MDR report key: 5221530 · Received November 13, 2015

    Report

    Report Number
    8010764-2015-00052
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    October 30, 2015
    Report Date
    October 30, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTT
    PMA / PMN Number
    K993289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 71129240 (B)(6) 2015); 151116 (B)(6) 2015); 110016 (B)(6) 2015) (B)(4). CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILED PLATE. THE LAG SCREW WAS CUT OUT OF THE FEMORAL HEAD AND THE COMPONENTS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751502 AMBI CHSP 6SL 140MM 130D TRAUMA INTERNAL FIXATION SYSTEM KTT SMITH & NEPHEW, INC. 13LT36442

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R (B)(4)