BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0X9MM FOSSA X-DR SCRW

    MDR report key: 3253740 · Received July 30, 2013

    Report

    Report Number
    0001032347-2013-00228
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 15, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK910038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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

    BASED ON THE RECEIPT OF THE OPERATIVE RECORDS IT WAS CONFIRMED THE CAUSE OF THE EVENT IS THE FOSSA IMPLANT WAS FRACTURED DUE TO THE PATIENT SUSTAINING A BLOW TO THE RIGHT FACE; THE THREE SCREWS WERE STILL SECURED TO THE BONE. THE THREE SCREWS WERE NOT EVALUATED AS THERE WAS NO ALLEGATION THEY DID NOT PERFORM AS INTENDED. BASED ON THE AVAILABLE CLINICAL AND MECHANICAL DATA, THE PROBABLE CAUSES OF FAILURE WERE MATERIAL FAILURE DUE TO TRAUMA AND BIOLOGIC FAILURE DUE TO NEUROMA. SUPPLEMENTAL REPORT THREE OF THREE FOR THE SAME EVENT, REFERENCE 1032347-2013-00226-1 AND 1032347-2013-00227-1.

    Description of Event or Problem · 1

    A REVISION SURGERY DUE TO A HISTORY OF TRAUMA AND PERSISTENT PAIN WAS REPORTED THROUGH THE (B)(6) STUDY.

    Description of Event or Problem · 1

    THE OPERATIVE RECORDS WERE RECEIVED, INDICATING THE PROCEDURES PERFORMED WERE 1. OPEN ARTHROPLASTY, RIGHT MANDIBULAR JOINT. 2. EXCISION OF NEUROMA TISSUE. 3. REMOVAL OF DEEP BURIED IMPLANT. IT IS REPORTED THE PATIENT DID WELL AND WAS STABLE FOR APPROXIMATELY 8 YEARS AND THEN SUSTAINED A BLOW TO THE RIGHT FACE. SUBSEQUENT TO THE TRAUMATIC EVENT, SHE BEGAN HAVING PREAURICULAR SWELLING PAIN AND DIFFICULTY OPENING. THE PATIENT WAS TREATED CONSERVATIVELY WITH MEDICAL MANAGEMENT AND EPISODIC STEROIDS. UPON DISSECTION DURING THE REVISION SURGERY IT WAS IDENTIFIED THERE WAS A FRACTURE LINE ALONG THE LATERAL FLANGE OF THE IMPLANT ITSELF AND ALTHOUGH THE 3 SCREWS WERE STILL SECURE IN BONE, THE LOWER AND LARGER PORTION OF THE IMPLANT HAD MOBILITY AS IT WAS NO LONGER CONNECTED TO ALL 3 OF THE 2.0MM SCREWS. THE IMPLANT WAS IRREPARABLE AND THEREFORE WAS REMOVED. NO VISIBLE POLYETHYLENE DEBRIS WAS NOTED. THE INTRA-OP ASSESSMENT ALSO SHOWED HEAVY SCAR TISSUE AND INTERPOSITIONAL TISSUE BETWEEN THE CONDYLAR HEAD AND THE FOSSA. THE SURGEON DECIDED NOT TO REINSERT ANOTHER FOSSA IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356376 2.0X9MM FOSSA X-DR SCRW BONE SCREW JEY BIOMET MICROFIXATION N/A 709101

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization