BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3241244 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04639
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT DUE TO SURGICAL DELAY OF 30 MINUTES OR GREATER. THE QUANTITY OF COMPLAINT SCREW WAS ORIGINALLY REPORTED AS ONE BUT ADDITIONAL INFORMATION RECEIVED BY THE SURGEON ON (B)(6) 2013, REPORTED MULTIPLE SCREWS. THE EXACT QUANTITY OF COMPLAINT SCREWS AND PART NUMBERS WAS REQUESTED, BUT NOT PROVIDED BY THE REPORTER. PLACEHOLDER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE SURGEON ON (B)(6) 2013, CONFIRMED THE COMPLAINT EVENT OCCURRED ON (B)(6) 2013. SURGEON STATED DURING THE PROCEDURE, MULTIPLE 5MM AND 6MM MATRIX SELF-DRILLING SCREWS BROKE WHILE PERFORMING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE TO TREAT A ZYGOMATICOMAXILLARY FRACTURE. THE COMPLAINT EVENT RESULTED IN MULTIPLE REPOSITIONING OF THE PLATES AND EXTENDED SURGICAL TIME BY 30 MINUTES OR MORE. PRE-DRILLING WAS NOT PERFORMED. THE THREADED PORTIONS OF THE BROKEN SCREWS REMAIN IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THOUGH REQUESTED, THE EXACT NUMBER OF BROKEN SCREWS AND THE ASSOCIATED PART NUMBERS WERE NOT PROVIDED BY THE SURGEON. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF TI MATRIXMIDFACE SCREWS SELF-DRILLING 6MM. THIS FOLLOW-UP #1 REPORT IS 3 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THREE 6MM MATRIX SELF DRILLING SCREW HEADS BROKE OFF DURING INSERTION. THE THREADED PORTIONS OF THE THREE SCREWS REMAINED IN THE PATIENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15 MINUTES DUE TO THE INCIDENT. THIS REPORT IS FOR ONE, TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341351 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention