BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 3242176 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04601
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING EVALUATION WAS PERFORMED ON FOUR SCREWS, LISTED AS A, B, C, AND D, PART NUMBER 04.617.816. THE MATERIAL OF THE SCREWS WAS NOT VERIFIABLE BECAUSE THERE WAS NO LOT REFERENCE. SCREWS A AND D WERE DAMAGED POST PRODUCTION, SOME RELEVANT FEATURES DID NOT MEET SPECIFICATION (NOT MANUFACTURING RELATED) AND THE UNDAMAGED FEATURES RESULTED CONFORMING. SCREWS B AND C WERE CONFORMING FROM A MANUFACTURING PERSPECTIVE; ALL RELEVANT MEASURABLE PRODUCT FEATURES MET SPECIFICATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE EVIDENCE PROVIDED BY THE RETURNED IMPLANTS SUGGESTS THAT TWO SCREWS WERE NOT COMPLETELY LOCKED TO THE CAUDAL HOLES. SINCE THE COMPLAINT DESCRIPTION DOES NOT SPECIFY THE SCREW BACK OUT LOCATION, THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A ZERO-P REVISION. A PATIENT WAS TREATED WITH ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT LEVELS C5-C6, C6-C7 ON (B)(6) 2013. THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND SHOWED TWO SCREWS HAD BACKED OUT OF ZERO-P PLATE AT C6-C7. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013; THE SURGEON REMOVED FOUR SCREWS AND THE PLATE AT C6-C7. THE PLATE AND SCREWS AT C5-C6 REMAINED INTACT AND IMPLANTED. THE PATIENT WAS THEN REVISED TO A BONE FILLER AND A DEPUY PLATE AND SCREWS AT C6-C7. THE PATIENT REPORTEDLY IS RECOVERING WELL. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342550 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention