BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4690271 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12841
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    March 31, 2015
    Report Date
    March 31, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CATALOG NUMBER: COMPLAINANT SCREW IS ONE OF TWO POSSIBLE PART NUMBERS: 400.456E: 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM; 400.456: 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM. DEVICE WAS NOT IMPLANTED OR EXPLANTED. PER FACILITY, THE COMPLAINANT PARTS WILL NOT BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. IF 400.456E, THE 510K IS K983485. IF 400.456, THE 510K IS K102656. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 REPORTED THAT MANDIBLE FRACTURED DURING A REVISION PROCEDURE ON (B)(6) 2015. THE PATIENT WAS INITIALLY TREATED FIVE (5) MONTHS AGO FOR PIERRE ROBIN SYNDROME WITH BILATERAL DISTRACTION USING A COMPETITOR¿S BIOMET INTERNAL RESORBABLE DISTRACTOR. DURING THAT OPERATION/APPLICATION, THE PATIENT¿S LEFT SIDE OF THE MANDIBLE FRACTURED. THE SURGEON PROCEEDED TO FIX THE FRACTURE AND PROCEEDED WITH THE DISTRACTION. DURING THE COURSE OF DISTRACTION (1-2 WEEKS), HOWEVER, THE BIOMET INTERNAL DISTRACTOR FAILED. THE SURGEON WAITED FIVE (5) MONTHS FOR THE BONE TO HEAL, THEN ATTEMPTED TO DISTRACT THE PATIENT AGAIN. THE SURGEON USED PROPLAN (VIRTUAL PLANNING) AND WANTED TO USE SYNTHES PEDIATRIC CURVILINEAR DEVICE. OSTEOTOMIES WERE PERFORMED ON THE PATIENT¿S LEFT POSTERIOR MANDIBLE USING PIEZO. IT WAS WHILE ATTEMPTING TO SCREW THE DISTRACTOR TO THE MANDIBLE (USING 1.3 X 6MM SCREWS) THAT THE MANDIBLE FRACTURED. THE SURGEON DECIDED NOT TO PROCEED ANY FURTHER WITH DISTRACTION DUE TO THE PATIENT¿S HISTORY OF POOR BONE QUALITY. A TONGUE LIP ADHESION WAS PERFORMED. EVERYTHING REPORTEDLY WENT WELL, ALTHOUGH THERE WAS A FIFTEEN (15) MINUTE DELAY IN THE COMPLETION OF THE PROCEDURE. PATIENT IS REPORTEDLY DOING WELL. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248754 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention