BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, ORBITAL, EXTRA-OCULAR

    MDR report key: 8636822 · Received May 23, 2019

    Report

    Report Number
    8030965-2019-64435
    Event Type
    Injury
    Date Received
    May 23, 2019
    Report Date
    April 24, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. CONCOMITANT MEDICAL PRODUCTS:COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM MESH IMPLANT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PEDEMONTE, C. ET AL. (2018), RECONSTRUCTION OF MEDIAL ORBITAL WALL USING A RETROCARUNCULAR APPROACH, JOURNAL OF CRANIO-MAXILLO-FACIAL SURGERY, VOL. 46, PAGES 1726-1730 (CHILE). THE PURPOSE OF THIS STUDY IS TO ANALYZE AND DESCRIBE THE USE OF THE RETROCARUNCULAR APPROACH FOR THE TREATMENT OF MEDIAL ORBITAL WALL FRACTURES. DURING JANUARY 2011 AND JANUARY 2017, A TOTAL OF 30 PATIENTS UNDERWENT ORBITAL RECONSTRUCTION TREATMENT WITH A RETROCARUNCULAR APPROACH TOGETHER WITH A TRANSCONJUNCTIVAL EXTENSION AND LATERAL CANTHOTOMY USING AN UNKNOWN SYNTHES TITANIUM MESH IMPLANT (MATRIXORBITAL). THE MINIMUM FOLLOW-UP WAS 6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT PRESENTED A DELAYED COMPLICATION ON THE 5TH DAY AFTER THE OPERATION, DEVELOPING A CONJUNCTIVAL GRANULOMA ON THE CARUNCLE OF THE AFFECTED EYE SOCKET. THE GRANULOMA WAS ASSOCIATED WITH A STITCH TO THE INFERIOR OBLIQUE MUSCLE AND WAS REMOVED IN AN EXPLORATORY SURGERY WITHOUT NEED TO REMOVE THE MESH TO RESOLVE IT. 1 PATIENT DEVELOPED DELAYED ENOPHTHALMOS OF THE EYE SOCKET THAT WAS OPERATED ON AFTER THE 1ST SURGERY, MAKING A 2ND SURGICAL INTERVENTION NECESSARY TO RESTORE THE LOST ORBITAL VOLUME USING CUSTOMIZED IMPLANTS. 1 PATIENT, THOUGH UNRELATED TO THE TYPE OF APPROACH USED, DEVELOPED POST-TRAUMATIC GLAUCOMA AFTER 2 MONTHS. THIS IS FOR AN UNKNOWN SYNTHES TITANIUM MESH IMPLANT (MATRIXORBITAL). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431993 IMPLANT, ORBITAL, EXTRA-OCULAR HQX OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention