BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVERSE/REVERSE NCB SCREW SYSTEM, 4.5 -48MM

    MDR report key: 2963267 · Received February 12, 2013

    Report

    Report Number
    9613350-2013-01344
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 29, 2012
    Report Date
    January 29, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES FOR REVIEW AND THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. AN UPDATED REPORT WILL BE SUBMITTED AS SOON AS DEVICE WILL BE RETURNED FOR INVESTIGATION AND THE RESULTS BECOMES AVAILABLE. ZIMMER REF # (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PT WAS IMPLANTED AN INVERSE/REVERSE NCB SCREW SYSTEM, 4.5 -48MM ON (B)(6) 2012 AND UNDERWENT REVISION OF TM GLENOID DUE TO INFECTION. DURING THE SURGERY, THE "HEAD COULD NOT BE DETACHED FROM THE BASE." THE SURGEON REPORTED THAT HE FOLLOWED THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61918 INVERSE/REVERSE NCB SCREW SYSTEM, 4.5 -48MM ZIMMER TRABECULAR METAL REVERSE SHOULD HSD ZIMMER GMBH 2645529

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L