BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM TI MLP CURVED STRUT PLATE-MINI 8 HOLES/MALLEABLE

    MDR report key: 4133418 · Received October 1, 2014

    Report

    Report Number
    2520274-2014-13860
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 6, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    PK974555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE NUMBER OF REPORTS FOR THIS EVENT CHANGED TO THREE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.0MM TI MLP CURVED STRUT PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED IT TO CONFORM WITH ALL REQUIREMENTS AT THE TIME OF ACCEPTANCE WITH NO ANOMALIES NOTED. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 447.315, LOT 7081090 MANDIBLE MINI-LOCKING PLATE WAS RECEIVED INTACT ALONG WITH 8 UNKNOWN SCREWS. THE COMPLAINT DESCRIPTION WAS FOR ADVERSE EVENT: POST-OPERATIVE INFECTION. THE PLATE AND SCREWS HOWEVER WERE RECEIVED DECONTAMINATED. NO ROOT CAUSE CAN THEREFORE BE DETERMINED FROM THE RETURNED PARTS. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. NO OTHER FEATURES RELATIVE TO POST-OPERATIVE INFECTION CAN BE DETERMINED BY THIS EVALUATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 FOR A MANDIBLE FRACTURE. ON (B)(6) 2014 THE PATIENT REPORTED POST-OPERATIVE PAIN AND PRESENTED WITH AN INFECTION AND WOUND DEHISCENCE. THE PATIENTS TOOTH WAS EXTRACTED ON (B)(6) 2014 DUE TO THE INFECTION. ON (B)(6) 2014 THE PATIENT PRESENTED WITH A LEFT ANGLE MANDIBLE INFECTION WITH EVIDENCE OF GRANULATION TISSUE AND PURULENT DRAINAGE ON EXPRESSION OF THE BUCCAL STAR. THE PLATE WAS REMOVED ON (B)(6) 2014 ALONG WITH 8 SCREWS DUE TO THE INFECTION, IT WAS NOTED AFTER REMOVAL ONE OF THE SCREWS HAD A MISSING TIP IT IS UNKNOWN WHEN THE TIP BROKE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLATE WAS REMOVED ON 09/04/2014 DUE TO AN INFECTION. NO ADDITIONAL DETAILS WERE PROVIDED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612757 2.0MM TI MLP CURVED STRUT PLATE-MINI 8 HOLES/MALLEABLE BONE PLATE JEY SYNTHES ELMIRA 7081090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention