BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

    MDR report key: 4268632 · Received November 21, 2014

    Report

    Report Number
    0001032347-2014-00397
    Event Type
    Injury
    Date Received
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    DZL
    PMA / PMN Number
    PK013557
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER THE CUSTOMER HAS BEEN CONTACTED MULTIPLE TIMES AND NO RESPONSE OR THE PRODUCT HAVE BEEN RECEIVED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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. FIELDS WERE UPDATED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A 915-2336 SCREW BROKE DURING SURGERY WHICH RESULTED IN A 45 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756961 LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW 2.0X5MM SUS PUSH SCR 2/PK DZL BIOMET MICROFIXATION N/A 642640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization