BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: MATRIXNEURO

    MDR report key: 20955185 · Received December 17, 2024

    Report

    Report Number
    9612488-2024-00003
    Event Type
    Injury
    Date Received
    December 17, 2024
    Manufacturer
    SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SANCHIN A, BERTELMANN E, HERNÁIZ DRIEVER P, TIETZE A, THOMALE UW. THE SUPRAORBITAL EYEBROW APPROACH IN PEDIATRIC NEUROSURGERY: PERSPECTIVES AND CHALLENGES OF FRONTAL KEYHOLE SURGERY. ADV TECH STAND NEUROSURG. 2023; 48:109-122. DOI: 10.1007/978-3-031-36785-4_5. PMID: 37770683. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVELY STUDY WAS TO PRESERVE STABLE VISION AND OCULOMOTOR FUNCTION. BETWEEN JANUARY 2013 AND APRIL 2022, A TOTAL OF 30 PATIENTS 28 MALE AND 12 FEMALE WITH MEAN AGE OF 8 ± 6.5 AND AGE RANGE WAS 0.3 TO 29.2 YEARS, SUPRAORBITAL EYEBROW APPROACHES WERE PERFORMED. THE BONY PORTION OF THE ORBITAL ROOF WAS REPLACED BETWEEN DURA AND PERIORBITAL LAYER, AND THE SUPRAORBITAL BONE FLAP WAS FIXED IN SITU BY USING TWO TITANIUM MICRO¬PLATES (MATRIXNEURO, DEPUY SYNTHES, WEST CHESTER, USA). MEAN FOLLOW-UP TIME WAS 23.4 ± 24.1 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN SYNTHES MATRIXNEURO. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: MATRIXNEURO (1 QTY). 1 PATIENT WITH A POSTOPERATIVE PERIORBITAL INFLAMMATION WAS TREATED BY SEROMA PUNCTURE AND SUCCESSFUL TARGETED ANTIBIOTIC TREATMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: MATRIXNEURO (1 QTY). 1 PATIENT INVOLVED ONE REVISION SURGERY DUE TO LOOSENING OF OSTEOSYNTHESIS MATERIAL. COSMETIC RESULT AS JUDGED BY THE PARENTS AND THE SURGEONS REMAINED EXCELLENT DURING FOLLOW-UP. NO POSTOPERATIVE HEMORRHAGE OR CEREBROSPINAL FLUID LEAK WAS OBSERVED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: MATRIXNEURO (1 QTY). 1 PATIENT INVOLVED ONE REVISION SURGERY DUE TO LOOSENING OF OSTEOSYNTHESIS MATERIAL. COSMETIC RESULT AS JUDGED BY THE PARENTS AND THE SURGEONS REMAINED EXCELLENT DURING FOLLOW-UP. NO POSTOPERATIVE HEMORRHAGE OR CEREBROSPINAL FLUID LEAK WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291703 UNK - PLATES: MATRIXNEURO PLATE, BONE JEY SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention