BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 20 HOLE PLATE 1.5MM THICK

    MDR report key: 4590735 · Received March 11, 2015

    Report

    Report Number
    3003506883-2015-10048
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    PK063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE MATRIXMANDIBLE PLATE IS BROKEN IN THREE PARTS AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS PLATE WAS MANUFACTURED IN NOVEMBER 2014 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE, WE HAVE TO ASSUME, THAT TOO MUCH LOAD HAS BEEN APPLIED ONTO THE IMPLANT DURING BENDING. PLEASE NOTE TITANIUM IMPLANTS SHOULD NEVER BE BENT FOR - AND BACKWARDS AS IT MAY WEAKEN THE PLATE OR EVEN MAY LEAD TO THE BREAKAGE OF THE PLATE. VISUAL INSPECTION: PLATE BROKEN IN THREE PARTS MATERIAL: PLATE IS MADE OF TICP, DIMENSIONS CAN NOT BE VERIFIED ANYMORE DUE TO THE DAMAGE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. PATIENT¿S YEAR OF BIRTH WAS REPORTED AS 1948. DEVICE BROKE INTRAOPERATIVE AND WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD: LOT 7850573 - SYNTHES (B)(4) MANUFACTURED THE TI MATRIXMANDIBLE 20 HOLE PLATE 1.5MM THICK, PART 04.503.718 AND LOT 7850573. INITIALLY, THE PART WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET. THE PARTS WERE RELEASED TO THE WAREHOUSE ON NOVEMBER 19, 2014. THERE WERE NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. DEVICE 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A MATRIX MANDIBLE PLATE BROKE INTRAOPERATIVE DURING BENDING. A SURGICAL DELAY OF THIRTY (30) MINUTES WAS NOTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166643 TI MATRIXMANDIBLE 20 HOLE PLATE 1.5MM THICK BONE PLATE JEY SYNTHES ELMIRA 7850573

    Patients

    Seq Age Sex Outcome Treatment
    1