BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM CANNULATED SCREW 32MM THREAD/60MM

    MDR report key: 3222723 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04339
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K962011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    PATIENT HAD TWO SCREWS PLACED IN HER ANKLE ON AN UNKNOWN DATE IN 1994. PATIENT BELIEVED SHE MAY BE HAVING A REACTION TO THE SCREWS. HER DOCTOR REQUESTED MATERIAL COMPOSITION OF THE PLATES, AND SPECIFICALLY IF IT CONTAINED (B)(4). PATIENT WAS TOLD THAT BOTH PARTS WERE 316L (B)(4), WHICH CONTAINS BETWEEN (B)(4). PATIENT COMMENTED THAT THE PERCENTAGE OF (B)(4) WAS HIGH FOR HER, SINCE SHE HAS LEARNED THAT SHE IS ALLERGIC TO (B)(4). PATIENT WILL SPEAK TO HER DOCTOR ABOUT HAVING SCREWS REMOVED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323344 7.0MM CANNULATED SCREW 32MM THREAD/60MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention