BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK SCR Ø2 SELF-TAP L8 TAN 1U I/CLIP

    MDR report key: 3061910 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-02001
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED SCREW IS INTACT AND SHOW ONLY SLIGHT WEAR. WE DO SUPPOSE THAT THESE DAMAGES WERE CAUSED DURING THE REVISION, POSSIBLY EXTRA FORCE HAD BEEN APPLIED AND LEAD TO THESE DAMAGES. NO PRODUCT FAULT COULD BE DETECTED. PRODUCT IS BEING SENT TO MANUFACTURING FOR EVALUATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE HEAD THREAD IS DAMAGED NEAR THE TOP OF THE HEAD. THERE IS ALSO SOME DAMAGED TO THE THREADS ON THE SHAFT. A FEW OF THE THREADS APPEAR TO BE SMASHED. THE THREAD PROFILE WAS CHECKED IN THE SECTION WITHOUT DAMAGE AND FOUND GOOD. DUE TO THE DAMAGE ON THE HEAD THREADS THE HEAD THREAD PROFILE COULD NOT BE EVALUATED. MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH MANDIBLE PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. POST-OPERATIVELY, IT WAS NOTICED THAT THERE WAS A MALOCCLUSION. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. DURING THE REVISION SURGERY, IT WAS REPORTED THAT A SCREW PULLED THROUGH A HOLE OF THE PLATE. ALL HARDWARE WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162859 LOCK SCR Ø2 SELF-TAP L8 TAN 1U I/CLIP JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention