BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVERSE/REVERSE SCREW SYSTEM, 4.5-30

    MDR report key: 4122322 · Received September 18, 2014

    Report

    Report Number
    9613350-2014-03893
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES FOR REVIEW. OTHER SOURCE DOCUMENTS (X-RAYS) WERE PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. ONCE MORE DETAILED INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED AN INVERSE/REVERSE SCREW SYSTEM, 4.5-30 ON (B)(6) 2014, ON THE RIGHT SIDE. AROUND (B)(6) 2014, THE PT FELT DISCOMFORT IN HIS SHOULDER. ON (B)(6) 2014, AN X-RAY WAS TAKEN, SHOWING A BROKEN SCREW AND A DISLOCATED BASEPLATE. AS A RESULT, THE PT WAS REVISED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579137 INVERSE/REVERSE SCREW SYSTEM, 4.5-30 ZIMMER TRABECULAR METAL REVERSE SHOULDER HSD ZIMMER GMBH 2720416

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R