BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI ORBITAL RIM PLATE 12 HOLES

    MDR report key: 6714607 · Received July 14, 2017

    Report

    Report Number
    3003506883-2017-10133
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Report Date
    June 17, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K021642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). 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

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 446.220, LOT# 7940973. MANUFACTURING LOCATION: ELMIRA, MANUFACTURING DATE: MAR 05, 2015. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7940973 OF 1.5MM TI ORBITAL RIM PLATE 12 HOLES 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 BILLET MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7810220) MET ALL SPECIFICATIONS. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD WAS COMPLETED. THERE WERE NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DATE OF POST-OPERATIVE PLATE BREAKAGE IS UNKNOWN. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). 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.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER WAS INADVERTENTLY REPORTED AS JULY 17, 2017 ON MEDWATCH REPORT (B)(4). THE CORRECT DATE SHOULD HAVE BEEN JUNE 17, 2017. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE ORBITAL RIM PLATE WAS CUT AND IMPLANTED IN PYRIFORM REGION IN AN ORTHOGNATHIC PROCEDURE FOR MAXILLARY ADVANCEMENT ON (B)(6) 2017. POSTOPERATIVE IMAGE REVEALED THE PLATE WAS BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REMOVAL OF BROKEN DEVICE. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME DESCRIBED AS MOBILE SEGMENT. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WENT THROUGH A ORTHOGNATHIC PROCEDURE OF MAXILLARY ADVANCEMENT. LEFORT 1 OSTEOTOMY WAS DONE WHEREIN BUTTRESSES WERE FIXED WITH L PLATES AND PYRIFORM WITH ORBITAL RIM PLATE CUT TO PIECES. POSTOPERATIVE IMAGE HAVE SHOWN BREAKAGE IN THE PLATE USED IN PYRIFORM REGIONS. THIS REPORT IS FOR ONE (1) 1.5MM TI ORBITAL RIM PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494724 1.5MM TI ORBITAL RIM PLATE 12 HOLES BONE PLATE JEY SYNTHES ELMIRA 7940973

    Patients

    Seq Age Sex Outcome Treatment
    1