BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2498287 · Received March 14, 2012

    Report

    Report Number
    8030965-2012-00102
    Event Type
    Injury
    Date Received
    March 14, 2012
    Report Date
    February 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE: (B)(4) 2011. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. POSSIBLE PART/LOT NUMBERS FOR SCREWS: 1X404.845/2766791, 1X404.830/2782088, 1X413.045/2784500, 1X413.040/2650854, 3X413.040/2767187, 1X413.035/2780945, 1X413.026/2651306, 1X413.026/2681691, 1X413.022/2716622. PMA/510K NUMBERS FOR POSSIBLE PART NUMBERS: K112583: 404.845: K000684: 413.040, 413.026, 413.022: K011815: 413.035: PREAMEND: 404.830. MFG DATES FOR POSSIBLE LOTS: (B)(4) 2010: 413.040/2650854: (B)(4) 2010: 413.026/2651306: (B)(4) 2010: 413.026/2681691: (B)(4) 2011: 404.845/2766791: (B)(4) 2011: 404.830/2782008, 413.045/2784500413.035/2780945: (B)(4) 2011: 413.022/2716622.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A HOSPITAL IN (B)(6) REPORTED: PT IMPLANTED ON AN UNK DATE WITH PLATE AND SCREWS HAD X-RAYS ON (B)(6) 2012 THAT SHOWED FIVE SCREWS LOOSE. MEDICAL SURGICAL INTERVENTION WAS NEEDED ON AN UNK DATE. IT IS KNOWN WHAT THE PT WAS REVISED TO. THIS IS 5 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW| PLATE