BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 SELF-TAP L10

    MDR report key: 4565192 · Received March 3, 2015

    Report

    Report Number
    3009450884-2015-10014
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 20, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    MQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT:400.810S / 9211525. VISUAL INSPECTION OF THE TWO BROKEN SCREWS SHOWS THAT ONLY THE SHAFTS WERE SENT. THE SCREW HEADS ARE NOT AVAILABLE. THEREFORE A CLEAR IDENTIFICATION IS NOT POSSIBLE. MICROSCOPIC INVESTIGATION SHOWS THAT BOTH SCREW HEADS ARE SHEARED OFF. DUE TO THE DAMAGE OF THE BROKEN SCREWS, IT IS NOT POSSIBLE TO MEASURE RELEVANT DIMENSIONS AT THE BROKEN AREA. DHR REVIEW SHOWS THAT THIS LOT WAS RELEASED AFTER FINAL INSPECTION WITHOUT ANY FINDINGS. USED MATERIAL CORRESPONDS WITH SPECIFICATION AS WELL. THEREFORE IT IS LIKELY THAT EXCEEDING APPLIED TORSIONAL FORCE WHILE INSERTION MAY HAVE CAUSED THE BREAKAGE. NO MANUFACTURING- OR MATERIAL RELATED ISSUE COULD BE IDENTIFIED. NO FURTHER INFORMATION WAS AVAILABLE. 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. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; 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.

    Description of Event or Problem · 1

    AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER AND REPORTED THE FOLLOWING: ¿IT IS REALLY DIFFICULT TO SEE ON THESE XRAYS IF ANY SCREWS ARE BROKEN ¿ THE RESOLUTION DOESN¿T ALLOW IT."

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HEAD OF THE TWO REPORTED CORTEX SCREWS WAS BROKEN DURING SURGERY. ONE SCREW HEAD WAS BROKEN WHEN THE SURGEON TRIED REMOVING IT TO INSERT ANOTHER LENGTH SCREW. THE OTHER ONE WAS BROKEN DURING INSERTION. THE AFFECTED PART HAD TO BE IMMOBILIZED BY PLASTER CAST. THERE WAS A DELAY IN THE REHABILITATION SCHEDULE. THERE WAS 10 MINUTES DELAY IN THE SURGERY. THIS REPORT IS 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148461 CORTSCR Ø1.5 SELF-TAP L10 MANDIBLE DISTRACTION DEVICES MQN SYNTHES GRENCHEN 9211525

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR