BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.8MM THICK

    MDR report key: 6740238 · Received July 25, 2017

    Report

    Report Number
    3000270450-2017-10250
    Event Type
    Injury
    Date Received
    July 25, 2017
    Report Date
    June 28, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF POSTOPERATIVE PLATE BREAKAGE IS UNKNOWN. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER IS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 04.503.773S, LOT # 3293465: THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 17.NOV.2009 EXPIRY DATE: 01.NOV.2019: 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. NON-STERILE 04.503.773 / 6000110 WAS MANUFACTURED IN US. DHR-REVIEW: NON-STERILE PART #: 04.503.773, LOT#: 6000110 (NON-STERILE) - TI MATRIXMANDIBLE 7X28 ANGLE RECON PL RIGHT 2.8 MM THICK. QUANTITY 8 WAS MANUFACTURED IN US: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 14-NOV-2008: REVIEWED IN-PROCESS ACCEPTANCE SHEET AND FINAL INSPECTION MEET ACCEPTANCE CRITERIA OF INSPECTION SHEET. COMPONENTS: RAW MATERIAL PART BK100225, 04.503.739 BILLET BP58, LOT: 5765735 REVIEWED. RAW MATERIAL RECEIVED FROM (B)(4) MANUFACTURING AND DESIGN COMPANY. INSPECTION SHEET FOR INSPECT DIMENSIONAL MEETS SPECIFICATION. CERTIFICATE OF COMPLIANCE RECEIVED FROM CAMERON MEET SPECIFICATION. NO 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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER. CUSTOMER QUALITY COMPLETED AN INVESTIGATION OF THE RETURNED DEVICES. THE FOLLOWING 11 DEVICES WERE RECEIVED; -- ONE (1) MATRIXMANDIBLE ANGLE RECONSTRUCTION PLATE (PART 04.503.773S / LOT 3293465 / REPORTED CONDITION- BROKEN: POSTOPERATIVELY). THE PLATE WAS RECEIVED WITH A ROUGHLY TRANSVERSE BREAK IN THE ANGLED PORTION OF THE PLATE. THIS PORTION OF THE PLATE IS A SHORT STRAIGHT SEGMENT WITH NO LOCKING HOLES. BOTH THE PROXIMAL AND DISTAL PORTIONS OF THE PLATE WERE RECEIVED. THE FRACTURE SURFACES WERE EXAMINED AND SHOW FLATTENING CONSISTENT WITH PRESSURE BETWEEN THE TWO SURFACES AFTER THE BREAK. THE ENDS OF THE PLATE EACH SHOW SMOOTHED EDGES CONSISTENT WITH CUTTING AND DEBURRING THE PLATE TO SIZE. THE PLATE ALSO SHOWS SIGNIFICANT CONTOURING. THE BALANCE OF THE PLATE SHOWS SURFACE WEAR CONSISTENT WITH IMPLANT FOR APPROXIMATELY 5.5 YEARS AND EXPLANT. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE PLATE IS ALREADY BROKEN. -- TEN (10) 2.4MM MATRIX MANDIBLE SCREWS (REPORTED PART FAMILY 04.503.44X.01S / LOTS UNKNOWN / REPORTED CONDITION- APPEARANCE/STATE NOT AS EXPECTED: CORROSION/RUSTING/PITTING). NOTE: INITIALLY 11 SCREWS WERE IDENTIFIED BUT, DURING THE INVESTIGATION, 2 PIECES WERE FOUND TO MAKE UP 1 SCREW. THUS, THE QUANTITY OF SCREWS IS DETERMINED TO BE 10. BACKGROUND: THE RETURNED PLATE AND SCREWS ARE PART OF THE MATRIX MANDIBLE PLATING SYSTEM. THE 2.8MM THINK RECONSTRUCTION PLATES (GOLD) MAY BE USED TO BRIDGE CONTINUITY DEFECTS WITHOUT BONE GRAFT PRIOR TO A SECONDARY RECONSTRUCTION. HOWEVER, THE TECHNIQUE GUIDE NOTES THAT ¿PLATE FRACTURE IS POSSIBLE WHEN ANY PLATE BEARS THE ENTIRE FUNCTIONAL LOAD FOR EXTENDED PERIODS. THEREFORE, THE IMPLANTATION OF BONE GRAFT IMMEDIATELY, OR AT A LATER DATE, IS NECESSARY TO SUPPORT THE CONSTRUCT. LOT NUMBER REVIEW: DEVICE HISTORY RECORD (DHR) REVIEW. PLATE 04.503.773S / 3293465: 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. MANUFACTURING DATE: 14-NOV-2008. DRAWING REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. --LARGE RECON, ANGLE PLATES, 2.8 THICK, 7X23 HOLES, MATRIX MANDIBLE: THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. THE PLATE THICKNESS AT THE BREAK WAS CONFIRMED TO BE WITHIN THE SPECIFICATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. RISK ASSESSMENT REVIEW: A RISK ASSESSMENT REVIEW WAS COMPLETED IN (B)(4). THE PLATE WAS FOUNDED TO BE ADEQUATELY ADDRESSED BY THE MATRIXMANDIBLE CORE DOSSIER DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT. 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

    THE CONDITIONS OF THE IMPLANTS ARE CONSISTENT WITH 5.5 YEARS OF IMPLANT AND USE OF A STRONG REMOVAL FORCE. AS THE CIRCUMSTANCES AT THE TIME OF THE ISSUE AND OVER THE IMPLANT DURATION (APPROXIMATELY) ARE UNKNOWN A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH THE PLATE AND SCREWS ON (B)(6) 2011, TO CROSSLINK THE SEPARATED PARTS DURING MANDIBULOTOMY FOR RIGHT-MANDIBULAR GINGIVAL CANCER. THE PLATE WAS BROKEN NEAR THE CORNER WITHOUT SUBJECTIVE SYMPTOMS. ALSO, THE COUPLE OF SCREWS¿ HEAD WERE TURNED TO BRITTLE AS IF THEY HAD BEEN CORRODED. THUS, IT WAS DIFFICULT TO REMOVE THE IMPLANTS BECAUSE THE DRIVER TIP DID NOT ENGAGE TO THE SCREWS. FINALLY, THE IMPLANTS COULD BE REMOVED. THE IMPLANTS WERE EXPLANTED ON (B)(6) 2017. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES REVISION SURGERY DUE TO POSTOPERATIVE BROKEN PLATE. THE INTRAOPERATIVE ISSUE OF DIFFICULT TO REMOVE THE IMPLANTS HAS BEEN REPORTED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) TI MATRIXMANDIBLE 7X23 ANGLE RECON PLATE RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519799 TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.8MM THICK BONE PLATE JEY SYNTHES SELZACH 3293465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention