BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.4 X 14MM HT X-DRIVE SCREW

    MDR report key: 1061726 · Received June 16, 2008

    Report

    Report Number
    1032347-2008-00030
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K001238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANOTHER DOCTOR WHO WAS PRESENT WHEN IMPLANTED AND EXPLANTED DOES NOT BELIEVE THE SCREWS BACKED OUT CAUSING THE PLATES TO BEND, BELIEVES THE PLATES WERE BENT AND HELD DOWN WHEN IMPLANTED, BELIEVES THE PLATES FLEXED AND MADE THE PLATES BOW. DOCTOR ALSO STATED PATIENT WAS NON-COMPLIANT AND BEGAN EATING "REAL FOOD" BEFORE HE WAS SUPPOSED TO. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. SEE REPORTS 1032347-2008-00029 TO -00031 (FOR THE THREE SCREW PART NUMBERS IN QUESTION). DOCTOR PRESENT WHEN IMPLANTED & EXPLANTED: ANOTHER DR.

    Description of Event or Problem · 1

    PLATES & SCREWS WERE IMPLANTED ABOUT A YEAR. THE PATIENT WAS HAVING REDNESS AND PAIN AT THE SITE. THEY WERE REMOVED BECAUSE THE SCREWS WERE BACKING OUT OF THE BONE AND CAUSED THE PLATES TO BEND, PER DOCTOR WHO REMOVED. WHEN THE IMPLANTS WERE REMOVED, IT WAS NOTED THE FRACTURE WAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 X 14MM HT X-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization 8 SCREWS (3 PART NUMBERS)| 2 PLATES (2 PART NUMBERS) WERE USED.