BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE

    MDR report key: 3954766 · Received July 24, 2014

    Report

    Report Number
    1719045-2014-10328
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    PK992891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO MATERIAL REVIEW REPORT NOR NON-CONFORMANCES GENERATED FOR THIS LOT. THE PARTS WERE INSPECTED AND CONFORMED TO SYNTHES INSPECTION SHEET. THE PARTS WERE RELEASED TO SYNTHES (B)(4) FOR ASSEMBLY. SYNTHES (B)(4) ASSEMBLED AND STERILE PACKAGED THE PARTS WITH NEW LOT NUMBER 6222387; THEY WERE RELEASED 9/22/2009. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED FOR A SHOULDER FRACTURE REPLACEMENT IN 2007. ON (B)(6) 2010, JUST UNDER HER SHOULDER THE DEVICES IMPLANTED FOR TREATMENT OF HER LEFT HUMERUS WAS NOTED TO BE LOOSE OR BACKING OUT ACCORDING TO AN X-RAY THAT WAS CONFIRMED BY THE PATIENT¿S PHYSICIAN. THE SURGEON MENTIONS THAT THE DEVICES WERE PROBABLY COMING LOOSE SINCE (B)(6) 2011. ADDITIONALLY A PIECE OF CABLE WORKED ITS WAY OUT OF HER ARM. IT WAS REPORTED THAT THE PATIENT HAD PAIN, IRRITATION AND DISCOMFORT. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 AT THE (B)(6) CLINIC AND WANTED TO KNOW IF ANY OF THE DOCUMENT DEVICES WERE RECALLED OR HAD ISSUES THAT THE CLINIC MAY NEED TO BE AWARE OF AT THE APPOINTMENT. THIS IS REPORT 4 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433616 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE CERCLAGE, FIXATION JDQ SYNTHES MONUMENT 6222387

    Patients

    Seq Age Sex Outcome Treatment
    1