BEUDAMED
    FDA Adverse Event Summary report: N

    LACTOSORB SCREW, 1.5X5MM

    MDR report key: 1911852 · Received December 1, 2010

    Report

    Report Number
    1032347-2010-00195
    Date Received
    December 1, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K955729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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 1032347-2010-00193 TO 195 AS DIFFERENT IMPLANTS WERE USED IN THE SAME CASE.

    Additional Manufacturer Narrative · 1

    RECEIVED LOT NUMBER. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.CORRECTED D2 CATALOG # FROM 915-2427 TO 915-2316.ALSO, AS 2 LOTS OF 915-2316 WERE USED IN THIS SURGERY, FILED MDR 1032347-2010-00201 FOR THE OTHER LOT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD LACTOSORB PLATES AND SCREWS IMPLANTED ON THE MAXILLARY BONE ON (B)(6) 2010. PATIENT SAW THE DOCTOR ON (B)(6) 2010 AND THERE WERE NO ISSUES. WHEN THE DOCTOR SAW THE PATIENT ON (B)(6) 2010, THERE WAS SWELLING AROUND THE IMPLANT SITE. PER THE PATIENT THE SWELLING HAD BEEN PRESENT SINCE (B)(6) 2010 AND SOME DISCHARGE OF PUS SINCE (B)(6) 2010. ON (B)(6) 2010 THE LACTOSORB PLATES AND SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB SCREW, 1.5X5MM BONE SCREW HWC BIOMET MICROFIXATION 298400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization