BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL

    MDR report key: 8864611 · Received August 6, 2019

    Report

    Report Number
    8030965-2019-66877
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    September 23, 2016
    Report Date
    July 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: THIS REPORT COMPLAINT NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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, 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHUNG, J.H. (2016), TRANSCONJUNCTIVAL INCISION WITH LATERAL PARACANTHAL EXTENSION FOR CORRECTIVE OSTEOTOMY OF MALUNIONED ZYGOMA, ARCHIVES OF CRANIOFACIAL SURGERY, VOL.17 (3), PAGES 119-127 (KOREA, SOUTH). THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE OUTCOMES FOLLOWING THE ZYGOMATICOFRONTAL SUTURE OSTEOTOMY TECHNIQUE USING TRANSCONJUNCTIVAL INCISION WITH LATERAL PARACANTHAL EXTENSION IN PATIENTS WHO UNDERWENT CORRECTION OF MALUNIONED ZYGOMA. BETWEEN JUNE 2009 TO SEPTEMBER 2015, A TOTAL OF 14 PATIENTS (8 MALES AND 6 FEMALES) WITH A MEAN AGE OF 48 YEARS (RANGE, 28¿69 YEARS), WERE INCLUDED IN THE STUDY. IF THE ZYGOMATIC REPOSITIONING CREATED AN INFERIOR ORBIT WALL DEFECT OR THE ORBIT HAD BEEN WIDENED BY THE PREVIOUS FRACTURE, THE ORBIT IS RECONSTRUCTED USING TITANIUM REINFORCED POLYETHYLENE MESH (SYNPOR, DEPUY SYNTHES INC., WARSAW, IN, USA). THE MEAN INTERVAL FROM INJURY TO OPERATION WAS 16 MONTHS (RANGE, 12 MONTHS TO 4 YEARS), AND THE MEAN FOLLOW-UP WAS 1 YEAR (RANGE, 4 MONTHS TO 3 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (THE ARTICLE DID NOT INDICATE WHICH PATIENT WERE IMPLANTED WITH SYNTHES DEVICE). A (B)(6) YEAR-OLD MALE PATIENT EXPERIENCED ORAL WOUND DEHISCENCE WITH SINUS ABSCESS THAT WAS TREATED BY WOUND IRRIGATION AND SINUS MUCOSA STRIPPING. 2 OF 6 PATIENTS WHO RECEIVED NERVE DECOMPRESSION, STILL EXPERIENCED NUMBNESS AFTER 1 YEAR. THESE IMPACTED PRODUCTS CAPTURE THE FOLLOWING ADVERSE EVENT: NUMBNESS AFTER 1 YEAR. THIS REPORT IS 4 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES SYNPOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660837 MESH, SURGICAL FTM OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention