BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 3013248 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-01010
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE THREAD ON THE SCREW HEAD IS BADLY DAMAGED. THE THREAD ON THE SCREW SHAFT SHOWS MARKS AND WEAR. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY IMPLANTATION AND EXTRACTION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SCREW WAS RECEIVED WITH DAMAGED LOCKING THREADS AND DAMAGED CANCELLOUS THREADS DISTALLY. THERE IS SOME ANODIZATION FADING AND A SLIGHTLY DEFORMED DRIVE RECESS AS WELL. THE PRODUCT DEVELOPMENT EVALUATION STATES THAT THE SCREW HAS DAMAGED LOCKING THREADS. THE CORRESPONDING IMPLANT REMAINS IN THE PATIENT SO THE MATING THREADS CANNOT BE EXAMINED ON THE PLATE. THERE ISN'T INFORMATION REGARDING THE ORIGINAL PROCEDURE AND WHETHER OR NOT THE TORQUE LIMITING HANDLE WAS USED. IT IS POSSIBLE THAT IF IT WAS NOT USED, THE THREADS WERE NEVER TRULY LOCKED TO THE PLATE CAUSING WEAR TO THE THREADS AND THE BACK OUT OF THE SCREW. BASED ON THE NUMBER OF SCREWS SOLD BETWEEN (B)(6) 2011 AND (B)(6) 2013, THE OCCURRENCE RATE IS APPROXIMATELY (B)(4). AS IT IS NOT KNOWN WHETHER OR NOT THE TORQUE LIMITING HANDLE WAS USED DURING THE INITIAL IMPLANTATION, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN STANDPOINT.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH ZERO-P HARDWARE ON (B)(6) 2012. DURING A FOLLOW UP APPOINTMENT, ABOUT ONE MONTH POST-OPERATIVE, SURGEON FOUND THAT ONE LOCKING SCREW AT LEVEL C5-C6 HAD BACKED OUT. PATIENT WAS ASYMPTOMATIC AND WOULD BE MONITORED, AND SURGEON DID NOT PLAN A REVISION AT THIS TIME. PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE, COMPLAINING THAT THE PREVIOUSLY REPORTED BACKED OUT SCREW WAS NOW CAUSING DISCOMFORT AND SHE WANTED IT REMOVED. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 AND SURGEON REMOVED ONE 3MM CERVICAL SPINE LOCKING SCREW FROM C6 LEFT SIDE. ALL OTHER HARDWARE REMAINED IMPLANTED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115724 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention