BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM

    MDR report key: 5062373 · Received September 8, 2015

    Report

    Report Number
    2520274-2015-15735
    Event Type
    Injury
    Date Received
    September 8, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM USER FACILITY 3500A FORM UF/IMPORTER REPORT NUMBER 06-0010-2015-02; PER CONTACT AT FACILITY REPORT WAS NOT PREVIOUSLY SUBMITTED TO THE FDA. 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 A WRIST REVISION SURGERY AND EXPLANT OF HARDWARE WAS PERFORMED ON (B)(6) 2015 AFTER IT WAS NOTED ON X-RAYS THAT THE PLATE WAS BROKEN AND THE PATIENT HAD NON-UNION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2015. DURING THE REVISION SURGERY THE ORIGINAL HARDWARE WAS REMOVED AND A NEW PLATE WAS IMPLANTED WITH BONE GRAFTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO SURGICAL DELAY RELATED TO THIS EVENT. THIS IS REPORT 1 FOR 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593671 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention