BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 8MM

    MDR report key: 5571306 · Received April 12, 2016

    Report

    Report Number
    1000562954-2016-10089
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 29, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    DZL
    PMA / PMN Number
    PK010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PER THE REPORTER, THE EXACT LOT NUMBER IS UNKNOWN. HOWEVER, THE DEVICE IS LIKELY FROM ONE OF THE THREE FOLLOWING LOTS: 9664130, 9821864, OR 9792729. AS ONLY POSSIBLE LOT NUMBERS ASSOCIATED WITH THE PROVIDED PART ARE KNOWN, THE FOLLOWING UDI NUMBERS ARE LIKELY: (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND IS NOT CONSIDERED TO HAVE BEEN IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR EACH OF THE THREE (3) POSSIBLE LOT NUMBERS FOR THE COMPLAINANT DEVICE WAS CONDUCTED WITH RESULTS AS FOLLOWS: LOT 9664130: MANUFACTURING SITE: (B)(4) - MANUFACTURING DATE: SEPTEMBER 28, 2015. NO NON-CONFORMANCE REPORTS (NCR) 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. LOT 9821864: MANUFACTURING SITE: (B)(4) - MANUFACTURING DATE: FEBRUARY 2, 2016. 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. LOT 9792729: MANUFACTURING SITE: (B)(4) - MANUFACTURING DATE: JANUARY 15, 2016. 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. 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 LEBANON AS FOLLOWS: IT WAS REPORTED THAT A 2.0MM INTERMAXILLARY FIXATION (IMF) SCREW BROKE PRIOR TO REACHING FULL INSERTION DURING A SURGICAL PROCEDURE ON (B)(6) 2016. THE SCREW BROKE BETWEEN THE HEAD AND THE BODY; ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE PROLONGATION. NO INFORMATION ABOUT PATIENT CONDITION WAS RECEIVED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225757 2.0MM IMF SCREW SELF-DRILLING 8MM SCREW FIXATION INTRAOSSEOUS DZL SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR