BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM LCP® RADIAL HEAD NECK PLATE 2 HOLES

    MDR report key: 3053454 · Received April 11, 2013

    Report

    Report Number
    3003506883-2013-10108
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 14, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K040777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REPORTED A SCREW WENT THROUGH ONE OF THE RADIAL HEAD PLATES. THE SYNTHES CONSULTANT WAS NOT PRESENT DURING THE PROCEDURE AND IS UNSURE OF WHAT PLATE (NECK OR RIM) OR SCREW WAS INVOLVED. UPDATE: (B)(6) 2012: THE SURGEON REPORTED TO CONSULTANT: DURING A RADIAL HEAD FRACTURE PROCEDURE, SURGEON WAS INSERTING THE 2.0MM CORTICAL SCREW AND THE SCREW WENT THROUGH THE PLATE. THE SURGEON USED 2.4MM LOCKING SCREW TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. EVENT #1 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154565 2.4MM LCP® RADIAL HEAD NECK PLATE 2 HOLES HRS SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1