BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 3232659 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04473
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE CORRECTED FROM (B)(6). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RESULTS OF THE MANUFACTURING EVALUATION SHOW THAT THE POINTED TIP IS BROKEN OFF; THE BROKEN OFF PORTION IS MISSING. ALL MEASURABLE DIMENSIONS WHICH ARE RELEVANT TO THE COMPLAINT SOURCE WERE CHECKED AND FOUND TO MEET TO THE SPECIFICATIONS. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL REVISION FOR A FAILED NON-SYNTHES MEDICAL DEVICE THE AWL BROKE ON THE BACK TABLE. THE PATIENT WAS NOT AFFECTED. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL REVISION THE ANGLED AWL FROM THE ZERO-P SET BROKE OFF WHILE THE SURGEON WAS PLACING THE ZERO-P AT THE C6-C7. THE SURGEON USED PICK UPS TO GRAB THE BROKEN PIECE. A BACKUP AWL WAS AVAILABLE AND THERE WAS NO DELAY IN THE PROCEDURE. THIS WAS A REVISION TO A PREVIOUS ANTERIOR PLATE THAT WAS USED TO FUSE C3-C6. THE ORIGINAL PLATE WAS A COMPETITORS DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334026 2.0MM ANGLED AWL OVE SYNTHES GMBH 3025898

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR