BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCIPITAL-PL 4.5/5 MED W/50 TI

    MDR report key: 3201892 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04216
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS IMPLANTED AND EXPLANTED ON UNKNOWN DATES. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ADDITIONAL EVALUATION REPORTS AS RECEIVED CONDITION TO BE THE OC-FUSION PLATE GOT CRACKED DURING INSERTION. THE OC-FUSION PLATE SHOWED A BREAKAGE OF THE PARTITION WALL ON THE RIGHT WING OF THE PLATE. THE CONVEX SIDE OF THE PLATE SHOWED A DISAPPEARANCE OF THE ANODIZED COLOR ALONG THE BENDED SECTION AND ALSO MARKS FROM BENDING INSTRUMENT. ON THE LATERAL VIEW SHOWS ONLY A SLIGHT BENDING ON THIS PORTION OF THE PLATE VISIBLE. THE RIGIDITY RELEVANT DIMENSIONS OF THE PLATE WERE CHECKED AND ARE IN SPECIFICATION. IN CONCLUSION THE PLATE SHOWS OBVIOUS SIGNS OF BENDING. REPEATED BENDING OF TITANIUM ALLOW MIGHT LEAD TO BREAKAGE. IT IS HOWEVER NOT POSSIBLE TO DRAW FINAL CONCLUSIONS BASED ON THE INFORMATION PRESENTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN INDIA AS FOLLOWS: AN OCCIPITAL CERVICAL FUSION SYSTEM PLATE CRACKED DURING INSERTION ON AN UNKNOWN DATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302625 OCCIPITAL-PL 4.5/5 MED W/50 TI KWP SYNTHES GMBH 7527345

    Patients

    Seq Age Sex Outcome Treatment
    1