BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7156842 · Received January 2, 2018

    Report

    Report Number
    2939274-2018-50004
    Event Type
    Injury
    Date Received
    January 2, 2018
    Report Date
    December 4, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEE, S: ET AL (2005) POROUS HIGH-DENSITY POLYETHYLENE FOR ORBITAL RECONSTRUCTION. ARCH OTOLARYNGOL HEAD NECK SURG, 131: 446-450. THIS REPORT IS FOR UNKNOWN TITANIUM PLATES. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LEE, S: ET AL (2005) POROUS HIGH-DENSITY POLYETHYLENE FOR ORBITAL RECONSTRUCTION. ARCH OTOLARYNGOL HEAD NECK SURG, 131: 446-450. (USA) THIS A RETROSPECTIVE REVIEW TO DETERMINE THE SAFETY AND EFFICACY OF USING POROUS HIGH-DENSITY POLYETHYLENE (PHDPE) IN THE REPAIR OF ORBITAL DEFECTS. PHDPE WERE PLACED IN 190 ORBITS IN 170 PATIENTS FROM MARCH 1998 TO OCTOBER 2003. FIVE PATIENTS UNDERWENT TUMOR EXTIRPATION THAT RESULTED IN A BONY ORBITAL DEFECT. ONE HUNDRED FORTY IMPLANTS WERE SINGE SHEET NON-CHANNELED PHDPE AND INVOLVED THE INFERIOR ORBITAL FLOOR, 35 IN THE MEDIAL ORBITAL WALL, 14 IN THE LATERAL ORBITAL WALL, AND 1 IN THE SUPERIOR ORBITAL WALL. IN 35 PATIENTS, PHDPE WAS USED TO REPAIR ORBITAL DEFECTS THAT ENCOMPASSED MORE THAN 1 ORBITAL WALL. ONE-MILLIMETER TITANIUM PLATES (SYNTHES, (B)(4)) WERE USED TO CANTILEVER THE CHANNELED IMPLANTS FROM THE ORBITAL RIM. THE AVERAGE LENGTH OF FOLLOW-UP FOR ALL PATIENTS WAS 7.4 MONTHS. COMPLICATIONS WERE NOTED IN 11 OF THE 170 PATIENTS. ONE CASE OF BLINDNESS RESULTED FROM A RETROBULBAR HEMATOMA DUE TO UNCONTROLLED HYPERTENSION, DESPITE AN EMERGENT CANTHOTOMY, REMOVAL OF IMPLANT, AND EVACUATION OF THE HEMATOMA. THE DISPLACEMENT OF 2 IMPLANTS RESULTED IN OBSTRUCTION OF THE MAXILLARY OSTIA, CAUSING MAXILLARY SINUSITIS. THE IMPLANTS WERE REMOVED, WITH NO FURTHER SEQUELAE. THERE WAS 1 CASE OF AN INFECTED SINGLE-CHANNEL IMPLANT (WITH A 1.0-MM TITANIUM MINIPLATE PLACED THROUGH A STANDARD TRANSCONJUNCTIVAL APPROACH), WITH AN ORBITAL ABSCESS REQUIRING REMOVAL AND DRAINAGE. THERE WERE 7 CASES OF PERSISTENT ENOPHTHALMOS AFTER PRIMARY REPAIR THAT REQUIRED REVISION. THREE OF OUR PATIENTS WITH PERSISTENT ENOPHTHALMOS WERE FOUND TO HAVE SLIPPED IMPLANTS AT THE TIME OF REOPERATION; REPLACING THESE IMPLANTS IN THEIR ANATOMICAL POSITION CORRECTED THE ENOPHTHALMOS. THESE CASES OF ENOPHTHALMOS WERE CORRECTED BY MEDIAL AND LATERAL AUGMENTATION OF THE ORBITAL WALLS WITH PHDPE. THERE WERE 3 CASES OF ECTROPION AND 1 CASE OF ENTROPION, 2 OF WHICH REQUIRED SURGICAL REVISION. THE SINGLE CASE OF ENTROPION OCCURRED AFTER A FORMAL LATERAL CANTHOTOMY INCISION, WHILE THE OTHER CASES OF EYELID MALPOSITION OCCURRED AFTER THE MODIFIED TRANSCONJUNCTIVAL APPROACH. ALL OF THESE CASES INVOLVED NONCHANNELED PHDPE. HOWEVER, ALL OF THESE CASES HAD COMMINUTED ORBITAL RIM DEFECTS THAT WERE REPAIRED WITH TITANIUM MINIPLATES. A COPY OF THE ARTICLE WILL BE SUBMITTED WITH THE MEDWATCH. THIS REPORT IS FOR UNKNOWN TITANIUM PLATES. THIS REPORT IS FOR 1 UNKNOWN PATIENT WHO EXPERIENCED BLINDNESS, 1 CASE OF INFECTED IMPLANT AND 7 CASES OF PERSISTENT ENOPHTALMOS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620 PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention