BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - RESORBABLE IMPLANTS

    MDR report key: 8784820 · Received July 12, 2019

    Report

    Report Number
    2939274-2019-59154
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    June 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    EZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ABSORBABLE MESH (RAPIDSORB)/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KIM, H.S., KIM, S.E., EVANS, G., AND PARK, S.H. (2012), THE USABILITY OF THE UPPER EYELID CREASE APPROACH FOR CORRECTION OF MEDIAL ORBITAL WALL BLOWOUT FRACTURE, PLASTIC AND RECONSTRUCTIVE SURGERY, VOL 130(4), PAGES 898-905 (USA). THE AIM OF THIS STUDY WAS TO OVERCOME THE PROBLEMS OF OTHER SURGICAL APPROACHES, THEY PROPOSED AN EYELID CREASE APPROACH THROUGH THE MEDIAL ONE-THIRD OF THE LID CREASE AND A 2- TO 3-MM SUPEROMEDIAL EXTENSION INCISION AS A CONSISTENT WAY OF RECONSTRUCTION MODERATE OR SEVERE BLOWOUT FRACTURES OF THE MEDIAL ORBITAL WALL AND INVESTIGATING THE USEFULNESS OF THIS APPROACH. FROM APRIL OF 2009 TO MARCH OF 2011, A TOTAL OF 22 PATIENTS (17 MALES AND 5 FEMALES) WITH A MEAN AGE OF 33.9 YEARS (RANGE 9-56 YEARS) UNDERWENT RECONSTRUCTION USING A TITANIUM MESH AND A POROUS POLYETHYLENE SHEET FROM OUR COMPETITOR'S AND AN UNKNOWN SYNTHES ABSORBABLE MESH (RAPIDSORB). FOLLOW-UP WAS 8 TO 28 MONTHS WITH AN AVERAGE OF 18.3 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS HAD REVISIONS IN THE INITIAL CASES WHERE THE POSTERIOR PART OF THE IMPLANT PROTRUDED INTO THE ORBITAL CAVITY AND THE SUPERIOR EDGE WAS LOCATED LATERAL TO THE SUPERIOR OBLIQUE MUSCLE. 2 PATIENTS COMPLAINED OF DIPLOPIA ON LATERAL GAZE FOR 6 MONTHS, WHICH IMPROVED WITH TIME. 2 PATIENTS WHO HAD MEDIAL AND INFERIOR ORBITAL WALL FRACTURE DEVELOPED MILD ENOPHTHALMOS (<1 MM). 2 PATIENTS DEVELOPED MILD HYPERTROPHIC SCAR AT THE JUNCTION OF UPPER LID CREASE AND SUPEROMEDIAL EXTENSION INCISION, BUT IMPROVED IN 6 MONTHS WITH CONSERVATIVE MANAGEMENT. PATIENT 2 HAD A REVISION SURGERY. THIS IS FOR AN UNKNOWN SYNTHES ABSORBABLE MESH (RAPIDSORB). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577827 UNK - RESORBABLE IMPLANTS SURGICAL MESH EZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention