BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    MDR report key: 4438217 · Received January 21, 2015

    Report

    Report Number
    2520274-2015-10518
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Report Date
    January 8, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION EVALUATION: PART 04.511.204.04C / UNKNOWN LOT: INSIDE THE SCREW SLOTS ARE VISIBLE DAMAGES, WHICH OCCURRED DUE TO MUCH MECHANICAL FORCE. NO OTHER DAMAGES ARE VISIBLE. THE MANUFACTURING DOCUMENTS FOR THE SCREWS COULD NOT BE REVIEWED AS THE LOT NUMBERS ARE UNKNOWN. THIS DAMAGE COULD HAVE OCCURRED DURING THE POSITIONING OF THE SCREW IF THE ANGLE WAS NOT CORRECT WHEN INSERTING INTO THE PLATE. AS NO PRODUCT FAULT COULD BE DETECTED, NO FURTHER ACTION REQUIRED. ASSOCIATED WITH K020087, K021642, K963546, AND K980199. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT REPORTED. EVENT DATE/IMPLANT DATE IS UNKNOWN. THIS REPORT IS FOR FIVE UNKNOWN MATRIX ORTHOGNATHIC SCREWS. PARTIAL CATALOGUE NUMBERS AND QUANTITIES WERE REPORTED AS FOLLOWS: 04.511.204 (3 EACH) AND 04.511.206 (2 EACH). LOT NUMBERS WERE NOT REPORTED. 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. 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: DURING AN UNKNOWN SURGICAL PROCEDURE THE SURGEON IMPLANTED A TITANIUM MATRIX ORTHOGNATHIC SPLIT PLATE AND FIVE UNKNOWN MATRIX ORTHOGNATHIC SCREWS. ONE SCREW WENT THROUGH THE PLATE WHEN THE SURGEON TRIED TO AFFIX THE PLATE. METALLIC SHAVINGS WERE ALSO REPORTEDLY GENERATED FROM ONE OF THE SCREWS DURING THE PROCEDURE. IT IS NOT KNOWN IF THE SHAVINGS WHERE GENERATED FROM THE SCREW THAT WENT THROUGH THE PLATE OR WERE FROM A DIFFERENT SCREW. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR FIVE UNKNOWN MATRIX ORTHOGNATHIC SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49648 1.85MM TI MATRIX SCREW SELF-TAPPING/4MM BONE, PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1