BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VBOSS 14MM SMALL ROUND ENDCAP

    MDR report key: 3504232 · Received December 6, 2013

    Report

    Report Number
    0009617544-2013-00483
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    August 25, 2013
    Report Date
    November 6, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MQP
    PMA / PMN Number
    K033837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER- 33661400SR & LOT NUMBER-112934 (3 UNITS OF VBOSS 14MM SMALL ROUND ENDCAP).CATALOG NUMBER- 33661405SR & LOT NUMBER- 086466 (2 UNITS OF VBOSS 14MM SMALL ROUND ENDCAP 5 DEG).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; LABELING REVIEW. RESULTS: THE CUSTOMER REPORTED EVENT OF THE VBOSS 14 MM SMALL ROUND ENDCAP WAS CONFIRMED BY THE SALES REP REPORT. THE ENDCAP BREAKAGE OCCURRED DURING PREPARATION FOR IMPLANTATION. MANUFACTURING RECORDS WERE REVIEWED AND DID NOT REVEAL ANY ANOMALIES RELATED TO THE EVENT. NO INSPECTION OF DEVICE BECAUSE DEVICE NOT RETURNED. CONCLUSION: THE ROOT CAUSE COULD NOT BE PIN POINTED DUE TO THE ABSENCE OF THE DEVICE. THE MOST PROBABLE CAUSE OF THE ENDCAP BREAKAGE IS AN EXCESSIVE IMPACTION FORCE WHILE INSERTING THE ENDCAPS ONTO THE CAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE 3 UNITS OF VBOSS 14MM SMALL ROUND ENDCAP, AND 2 UNITS OF VBOSS 14MM SMALL ROUND ENDCAP 5 DEG, HAD BROKEN AT THE SAME TIME. THE SURGEON WAS STILL IMPLANT ABLE TO IMPLANT THE CAGE AND COMPLETE THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE 3 UNITS OF VBOSS 14MM SMALL ROUND ENDCAP, AND 2 UNITS OF VBOSS 14MM SMALL ROUND ENDCAP 5 DEG, HAD BROKEN AT THE SAME TIME. THE SURGEON WAS STILL IMPLANT ABLE TO IMPLANT THE CAGE AND COMPLETE THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634241 VBOSS 14MM SMALL ROUND ENDCAP IMPLANT-INTERBODY MQP STRYKER SPINE-FRANCE 112934

    Patients

    Seq Age Sex Outcome Treatment
    1