BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/85MM

    MDR report key: 5673034 · Received May 23, 2016

    Report

    Report Number
    2520274-2016-12800
    Event Type
    Injury
    Date Received
    May 23, 2016
    Report Date
    May 8, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. ADDITIONAL PRODUCT CODE: JDO. (B)(4). UNKNOWN DATE IN (B)(6) 2015. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 DEVICES INITIALLY IMPLANTED IN (B)(6) 2015 WERE EXPLANTED ON (B)(6) 2016 TO ADDRESS A PATIENT'S AVASCULAR NECROSIS OF THE FEMORAL HEAD. FIVE SYNTHES DEVICES WERE EXPLANTED: A 145 DEGREE, 2-HOLE DHS PLATE; A ONE-STEP LAG SCREW; TWO 4.5MM CORTEX SCREWS; AND AN UNKNOWN 6.5 CANNULATED SCREW, 85MM LENGTH WITH 16MM THREAD. ALL PREVIOUSLY IMPLANTED DEVICES WERE REMOVED INTACT AND THE PATIENT WAS REVISED TO A DEPUY TOTAL HIP. THERE WERE NO SURGICAL DELAYS, NO MEDICAL INTERVENTION REQUIRED DURING THE SURGERY AND THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328450 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/85MM APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention