BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM

    MDR report key: 6455721 · Received April 4, 2017

    Report

    Report Number
    2520274-2017-11171
    Event Type
    Injury
    Date Received
    April 4, 2017
    Report Date
    March 17, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: JDO. (B)(4). ORIGINAL IMPLANT DATE WAS SOMETIME IN (B)(6) 2010 IN (B)(6). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE PATIENT FELT THAT THE DEVICE WAS RUBBING AND FELT SHE MAY HAVE AN ALLERGIC REACTION TO THE DEVICE. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS DETERMINATION WILL BE REVIEWED ACCORDINGLY. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HARDWARE REMOVAL WAS DONE FOR IMPLANTS THAT WERE ORIGINALLY IMPLANTED IN (B)(6) 2010. THE PATIENT STATES THAT THE IMPLANTS WERE RUBBING, BUT NOW SHE IS WONDERING IF SHE HAD AN ALLERGIC REACTION TO THE MATERIAL. THE PHYSICIAN STATED THAT THE PATIENT DID NOT HAVE A LOT OF PADDING AND IS A SMALL PERSON SO IT COULD BE PROBLEMATIC. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239558 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention