BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 7152325 · Received December 28, 2017

    Report

    Report Number
    8030965-2017-50992
    Event Type
    Injury
    Date Received
    December 28, 2017
    Report Date
    December 1, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR UNKNOWN TITANIUM MESH/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: OTERO-RIVAS, M; ET AL (2015) TITANIUM MESH IN RECONSTRUCTIVE SURGERY OF THE NASAL PYRAMID. FOLLOW-UP OF OUR 11 INITIAL CASES. INT. JOURNAL OF DERMATOLOGY, (54) 961-965. (SPAIN/USA) THIS IS A RETROSPECTIVE REVIEW OF 11 PATIENTS WITH NON-MELANOMA SKIN CANCER WHO HAD RECONSTRUCTION OF THE NASAL PYRAMID. IN THE RECONSTRUCTION, FULL-THICKNESS NASAL DEFECT AND LOCAL FLAPS WERE USED EMPLOYING TITANIUM MESH (SYNTHES-STRATEC) AS SUPPORT STRUCTURES. NO MESH EXTRUSIONS, INFECTIONS, OR COLLAPSE OF THE NASAL VALVE WERE NOTED IN PATIENTS WITH A MEAN FOLLOW-UP OF FIVE YEARS. THERE WERE 3 MEN AND 8 WOMEN, MEAN AGE AT THE TIME OF SURGERY WAS 75.63 YEARS. THE MEAN DIAMETER WAS 2.5 CM. SIX OF THE TUMORS WERE PRIMARY, WHILE 5 OF THEM WERE RECURRENT. THE MEAN FOLLOW-UP TIME WAS 59.63 MONTHS (MAXIMUM 88, MINIMUM 36 MONTHS). NONE OF THEM HAD ANY TYPE OF POSTSURGICAL COMPLICATIONS SUCH AS INFECTION, EXTRUSION, OR NASAL VALVE COLLAPSE. PATIENT 8 WAS LOST TO FOLLOW-UP THREE YEARS LATER BECAUSE SHE DIED OF A PRIMARY CUTANEOUS APOCRINE ADENOCARCINOMA THAT BY THE TIME OF DIAGNOSIS HAD ALREADY SPREAD TO THE AXILLARY NODES. PATIENT 9 NEEDED REVISION SURGERY TO PERFORM DEBULKING OF THE FLAP. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN TITANIUM MESH. PATIENT 9, (B)(6) MALE REQUIRED REVISION SURGERY FOR DEBULKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932030 BONE PLATE JEY OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention