BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE, PLATE

    MDR report key: 4484990 · Received February 4, 2015

    Report

    Report Number
    2520274-2015-10770
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 21, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.RECEIVED DEVICE WAS REPORTED AS BEING EITHER PART NUMBER 04.503.103.01C OR 04.503.104.01C. COMMON DEVICE NAME, DEVICE PRODUCT CODE AND 510(K) WERE IDENTIFIED. SUBJECT DEVICE BROKE DURING IMPLANTATION AND THEREFORE, WAS NOT CONSIDERED TO HAVE BEEN IMPLANTED. THIS FIELD SHOULD HAVE REMAINED UNPOPULATED. 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 ORIGINAL DATE OF AWARENESS WAS REPORTED IN ERROR AS JANUARY 19, 2015 ON THE INITIAL MEDWATCH. THE CORRECT DATE OF AWARENESS FOR THIS COMPLAINT WAS JANUARY 21, 2015.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.

    Additional Manufacturer Narrative · 1

    REPORTER NOT SURE IF PART NUMBER IS 04.503.103.01C OR 04.503.104.01C FOR UNKNOWN MATRIX NEURO SCREWS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: AN INVESTIGATION WAS PERFORMED; THE RETURNED SCREW SHOWS THAT ONE IS COMPLETELY BROKEN OFF, ON THE OTHER TWO SCREWS IT WAS EVIDENT THAT THE TIP GOT SLIGHTLY DAMAGED AND BROKEN OFF. TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED AND RESULTED IN THESE DAMAGES. THE RAW-MATERIAL CERTIFICATES AND THE MANUFACTURING PAPERS ARE NOT AVAILABLE FOR EXAMINATION. BASED ON THESE FINDINGS AND WITHOUT DETAILED INFORMATION, THE PRODUCT FAULT COULD BE EXCLUDED. NO PRODUCT FAULT COULD BE DETECTED. 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 WAS RECEIVED FROM (B)(6).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREW NOT ADVANCING IN BONE AND THE HEAD SHEERED OFF. THERE WERE 3 SCREWS, 2 SPINNING NOT ADVANCING, BUT THE 3RD ONE HEAD SHEERED OFF AS SOON AS THEY STARTED INSERTING. NO COMPLICATIONS FOR THE PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81824 BONE, PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR