BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISUALIF 5.5 X 33MM CONSTRAINED SCREW

    MDR report key: 3213419 · Received June 20, 2013

    Report

    Report Number
    3006404071-2013-00007
    Event Type
    Other
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SPINESMITH HOLDINGS, LLC
    Product Code
    OVD
    PMA / PMN Number
    K122168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MATERIAL AND PROCESSING REQUIREMENTS WERE TO SPECIFICATION FOR THE RELEVANT PARTS. REVIEW OF PRODUCT LABELING AND THE SYSTEM SURGICAL TECHNIQUE DID NOT REVEAL ANY DISCREPANCIES OR DEFICIENCIES. EVALUATION OF THE POST-OPERATIVE X-RAY SUGGESTS THAT THE SCREW WAS PLACED AT A 35 DEGREES ANGLE WHILE THE DRILL AND SCREW GUIDES AND SURGICAL TECHNIQUE PLACE IT AT A 10 DEGREES ANGLE. THE IMPLANTS ARE STILL IN THE PT AND WERE NOT RETURNED TO DETERMINE ANY POSSIBLE DAMAGE TO THE SCREW RETENTION FEATURE. NOTE: THE INFORMATION CONTAINED IN THIS REPORT REPRESENTS THE MOST COMPLETE AND UP-TO-DATE INFORMATION AVAILABLE. IT DOES NOT CONSTITUTE ANY ADMISSIONS, BUT PRESENTS THE RESULTS OF THE INVESTIGATION BASED ON THE INFORMATION AVAILABLE. THIS IS THE FINAL REPORT. SHOULD ANY ADDITIONAL DETAILS BECOME AVAILABLE THAT IMPACTS OR CHANGES THE INFORMATION CONTAINED IN THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP EXAMINATION ON (B)(6) 2013, THE SURGEON FOUND THAT A SCREW HAD PASSED THROUGH THE PLATE FLANGE. ACCORDING TO THE INITIAL REPORTER, THE SCREW PASSED THROUGH THE PLATE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281090 VISUALIF 5.5 X 33MM CONSTRAINED SCREW VISUALIF ALIF SYSTEM OVD SPINESMITH HOLDINGS, LLC 0306-5533 88AQ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other