BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZNN CMN LAG SCREW 10.5X105

    MDR report key: 3002019 · Received March 11, 2013

    Report

    Report Number
    9613350-2013-01409
    Event Type
    Other
    Date Received
    March 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT YET RECEIVE THE EXPLANTED PRODUCTS FOR REVIEW. AS NO LOT NUMBER IS KNOWN, THE REVIEW OF THE QUALITY RECORDS COULD NOT BE PERFORMED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND (B)(4)CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A ZNN CMN LAG SCREW 10.5X105 ON AN UNKNOWN DATE. DURING EXPLANTATION OF THE SCREW ON (B)(6) 2013, THE LAG SCREW SHEARED UPON ATTEMPTED REMOVAL. IT WAS FURTHER REPORTED THAT "NO SET SCREW ENGAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101061 ZNN CMN LAG SCREW 10.5X105 ZNN CMN LAG SCREW 10.5X105 HSB ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other