BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 7X23 ANGLE RECON PL LEFT 2.5MM THICK

    MDR report key: 6898522 · Received September 27, 2017

    Report

    Report Number
    3000270450-2017-10340
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 6, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION WAS COMPLETED. THE DEVICE WAS RECEIVED LOOSE IN A BAG AND WAS LASER ETCHED P/N 04.503.739 LOT# 9972624. THE PLATE WAS RECEIVED BROKEN INTO TWO SEGMENTS BETWEEN THE SIXTH AND SEVENTH HOLES FROM THE BEAM ON THE 23-HOLE LEG. A VISUAL INSPECTION OF THE MATRIXMANDIBLE RECONSTR. PLATE ANGLED, LEFT, 7 + 23 HOLES, 2.5MM SHOWED THAT THE PLATE IS BENT/TWISTED AND HAS HEAVY GOUGES ON THE HOLES SURROUNDING THE BREAK. THE PLATE WAS ALSO MISSING THE SIXTH AND SEVENTH HOLES ON THE 7-HOLE LEG. RELEVANT FEATURES WERE MEASURED ON THE SIXTH AND SEVENTH HOLES AS THE SPACE BETWEEN THE SIXTH AND SEVENTH HOLE IS DAMAGED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE FOR SHIPMENT WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IT WAS CONCLUDED ANY DAMAGE, BREAKAGE, GOUGES/SCRATCHES OR OUT OF SPECIFICATION CONDITION DUE TO DAMAGE OCCURRED AFTER THE PRODUCT LEFT MANUFACTURING. NO MANUFACTURING RELATED DEVIATION COULD BE FOUND. AS DESCRIBED IN THE COMPLAINT DESCRIPTION "THE PRE-BENDING WAS PERFORMED BY USING BENDING PLIERS". IT CAN BE ASSUMED THAT THIS HAS LED TO THE PLATE BREAKAGE. 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

    LOT# OF CONCOMITANT DEVICE UPDATED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR NON-STERILE PART# 04.503.739, LOT# 9972624. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 14, 2016. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 9972624 OF TI MATRIXMANDIBLE 7X23 ANGLE RECON PL LEFT 2.5MM THICK WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THAT ALL SPECIFICATIONS WERE MET AND NO ANOMALIES NOTED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. (B)(4). DEVICE IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER ADDRESS AND PHONE NUMBER IS NOT PROVIDED FOR REPORTING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 04.503.739S, LOT # 9818942: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 10.FEB.2016 EXPIRY DATE: 01.OCT.2026: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DHR FOR NON-STERILE PART IS PENDING COMPLETION. 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.

    Description of Event or Problem · 1

    CONCOMITANT DEVICE REPORTED: BENDING PLIERS W/NOSE, F/MATRIXMANDIBLE PLATES (PART# 03.503.056, LOT# T926074, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE BROKE WHEN THE SURGEON PERFORMED PRE-BENDING ALONG THE BONE MODEL DURING THE PREPARATION FOR THE MANDIBLE TUMOR SURGERY ON (B)(6) 2017. THE PRE-BENDING WAS PERFORMED BY USING BENDING PLIERS. THE SURGEON COMMENTED THAT THE S/HE DID NOT BEND BACK THE PLATE DURING BENDING. THERE WAS NO PATIENT INVOLVED AS IT HAPPENED BEFORE THE SURGERY. CONCOMITANT DEVICE REPORTED: BENDING PLIERS W/NOSE, F/MATRIXMANDIBLE PLATES (PART # 03.503.056, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI MATRIXMANDIBLE 7X23 ANGLE RECON PLATE LEFT 2.5 MM THICK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676530 TI MATRIXMANDIBLE 7X23 ANGLE RECON PL LEFT 2.5MM THICK BONE PLATE JEY SYNTHES SELZACH 9818942

    Patients

    Seq Age Sex Outcome Treatment
    1