BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY EXPLANT SILICON SCR DRV BLACK

    MDR report key: 4951701 · Received July 28, 2015

    Report

    Report Number
    9613350-2015-00842
    Event Type
    Other
    Date Received
    July 28, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR OTHER SOURCE DOCUMENTS FOR REVIEW. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED. EVENT DESCRIPTION: LASER MARKING IS NOT LEGIBLE. AS THE INSTRUMENT HAS NOT BEEN RETURNED, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED FOR THIS PRODUCT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES FOR REVIEW. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AT HOSPITAL, UPON RECEIPT OF ORIGINAL PACKED INSTRUMENT, IT WAS DETECTED THAT THE LASER MARKING OF THE DEVICE IS ILLEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488074 EASY EXPLANT SILICON SCR DRV BLACK EASY EXPLANT SILICON SCREW DRIVER HXX NORMED MEDIZIN-TECHNIK GMBH NA 185D14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other