BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER FOR

    MDR report key: 3001829 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-10097
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MANUFACTURING RECORDS WERE RECEIVED AND NO COMPLAINT RELATED ISSUES WERE FOUND. OUR INSPECTION SHOWED THAT THE TIP OF THE SYNFIX IMPLANT HOLDER WAS BROKEN OFF AND BLOCKED IN THE IMPLANT. AS THE BROKEN PORTION WAS BLOCKED IN THE IMPLANT, THE RELEVANT DIMENSIONS COULD NOT BE MEASURED. THE EXACT CAUSE OF THE OCCURRENCE COULD NOT BE DETERMINED. THE FRACTURE FACE WAS HOMOGENOUS, WHICH INDICATED MATERIAL CONFORMITY. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) L3-L4 PROCEDURE, THE SURGEON WAS INSERTING A SYNFIX LR 26MM IMPLANT WITH THE IMPLANT HOLDER, AND THE TIP OF THE HOLDER BROKE OFF INSIDE THE IMPLANT. SURGEON REMOVED THE IMPLANT, SELECTED ANOTHER AND COMPLETED THE PROCEDURE. THIS COMPLAINT IS ON THE HOLDER. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60227 IMPLANT HOLDER FOR LXH SYNTHES GMBH 2165086

    Patients

    Seq Age Sex Outcome Treatment
    1