BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TITANIUM MESH IMPLANT

    MDR report key: 12353940 · Received August 23, 2021

    Report

    Report Number
    2939274-2021-04808
    Event Type
    Injury
    Date Received
    August 23, 2021
    Report Date
    July 25, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNK - SCREWS: TITANIUM MESH IMPLANT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GEBRAN, S.G. ET AL. (2021), SURGICAL TREATMENT AND VISUAL OUTCOMES OF ADULT ORBITAL ROOF FRACTURES, PLASTIC AND RECONSTRUCTIVE SURGERY, VOL. XX, PAGES 1-12 (USA). THE PURPOSE OF THIS STUDY WAS TO EXAMINE AND CHARACTERIZE THE INCIDENCE, CAUSE, PRESENTATION, AND MANAGEMENT OF ORBITAL ROOF FRACTURES IN ADULTS WHO PRESENT TO A SINGLE, LEVEL I, TERTIARY CARE CENTER FROM 2015 TO 2018. FROM NOVEMBER OF 2015 TO DECEMBER OF 2018, A TOTAL OF 55 PATIENTS WERE TREATED FOR FACIAL FRACTURES OF WHOM 8 RECEIVED SURGICAL TREATMENT FOR ORBITAL ROOF FRACTURES. A TOTAL OF FIVE PATIENTS HAD BOTH THE SUPERIOR ORBITAL RIM AND ORBITAL ROOF REPAIRED. AS FOR SURGICAL APPROACH, FOUR PATIENTS HAD CORONAL INCISIONS TO REPAIR OTHER FACIAL FRACTURES, AND TWO HAD A SUBBROW INCISION (ONE AS A PRIMARY APPROACH AND ONE THROUGH A LACERATION). FOUR OF THE ROOF REPAIRS WERE PERFORMED USING A MICRO¿TITANIUM MESH PLATE (DEPUY SYNTHES, RAYNHAM, MASS.). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD FEMALE PATIENT DIED IN-HOSPITAL. A (B)(6) YEAR-OLD MALE PATIENT HAD NO LIGHT PERCEPTION BILATERALLY. 31 PATIENTS HAD SEVERE OCULAR COMPLICATIONS. 19 PATIENTS HAD TRAUMATIC OPTIC NEURPATHY. 11 PATIENTS HAD RETROBULBAR HEMATOMA. 10 PATIENTS HAD MACULAR COMMOTION RETINAE. THIS IS FOR AN UNKNOWN SYNTHES TITANIUM MESH PLATE. THIS REPORT IS FOR ONE (1) UNK - SCREWS: TITANIUM MESH IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251168 UNK - SCREWS: TITANIUM MESH IMPLANT SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1