BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.3MM CANNULATED SCREW 32MM THREAD/100MM

    MDR report key: 2833021 · Received November 1, 2012

    Report

    Report Number
    2520274-2012-02810
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Report Date
    October 3, 2012
    Product Code
    HWC
    PMA / PMN Number
    K962011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    COMPLAINT DEPARTMENT ENGINEER RECEIVED CALL FROM PT: PT IN 2003 UNDERWENT REVISION OF A PREVIOUS, POORLY HEALED, LEFT LEG FRACTURE, INJURY 1986. DURING THE REVISION, THE PT WAS IMPLANTED WITH A TITANIUM ROD AND OTHER STAINLESS IMPLANTS, REPORTEDLY, NON SYNTHES PRODUCT. POST OPERATIVELY, THE PT EXPERIENCED EXTREME FATIGUE AND ALLERGIC SYMPTOMS. AT THE SAME TIME, HE DEVELOPED A RED RASH ON THE SKIN EXPOSED TO A TITANIUM WATCH. SUBSEQUENT ALLERGY TESTING WAS POSITIVE FOR TITANIUM 3 AND NICKEL 4. IN 2008, ALL HARDWARE WAS REMOVED, HOWEVER, ALLERGIC SYMPTOMS PERSISTED. THE PT FRACTURED HIS HIP ON (B)(6) 2012 AND WAS IMPLANTED WITH 3 SYNTHES SCREWS ON (B)(6) 2012. THE PT IS NOW IN A REHAB FACILITY AND IS EXPERIENCING EXTREME FATIGUE, AND MUSCLE PAIN AND CRAMPING IN THE JAW AND NECK. THE PTS SURGEON HAS TOLD THE PT THAT THE IMPLANTS MUST REMAIN IN PLACE FOR 1 YEAR. ENGINEER CONFIRMED THE PART NUMBERS CORRESPONDED TO SYNTHES PRODUCTS AND THE MATERIAL FOR THOSE PART NUMBERS WAS STAINLESS STEEL WHICH CONTAINED BETWEEN 13 AND 15 PERCENT NICKEL. THE PT ASKED IF THERE WERE AVAILABLE IMPLANTS THAT DID NOT CONTAIN EITHER NICKEL OR TITANIUM. HE REQUESTED A LETTER WITH THE MATERIAL COMPOSITION OF THOSE SCREWS WHICH WAS SENT ON (B)(6) 2012. HE MADE A POINT OF SAYING HE WAS NOT COMPLAINING ABOUT THE DOCTOR OR THE IMPLANTS, JUST THAT HE NEEDED TO KNOW THE COMPOSITION TO SEE IF HE NEEDED THEM REMOVED. THE PT WAS REFERRED TO HIS PHYSICIAN REGARDING THE IMPLANTS. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.3MM CANNULATED SCREW 32MM THREAD/100MM CANNULATED SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1