BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL SPACER-TR 12MMX33MM 7MM HEIGHT

    MDR report key: 3760292 · Received April 19, 2014

    Report

    Report Number
    3000270450-2014-10012
    Event Type
    Malfunction
    Date Received
    April 19, 2014
    Date of Event
    March 26, 2012
    Report Date
    March 30, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    MQP
    PMA / PMN Number
    PK011037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW DEVICE HISTORY REVIEW WAS REQUESTED TO BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE AS RECEIVED CONDITION OF THE IMPLANT WAS BROKEN INTO FOUR PIECES WITH ADDITIONAL MARKS AND SCRATCHES ON THE SURFACE FINISH. MEASUREMENT OF THE IMPLANT WIDTH WAS UNOBTAINABLE. ALL OTHER RELEVANT DIMENSIONAL FEATURES WERE MEASURED AND PASSED PER THE CORRESPONDING PROCESS DOCUMENTATION. INSPECTION / MEASUREMENT OF THE RETURNED PART SHOWED THAT IT MEETS ALL DIMENSIONAL REQUIREMENTS FOR UNDAMAGED FEATURES. FEATURES AT THE LOCATION IN WHICH THE PLATE BROKE WERE UNOBTAINABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORD REVIEW: PART NUMBER 08.804.167 AND LOT NUMBER 5157716 HAD NO NON-CONFORMANCE REPORTS. VERTEBRAL SPACER- TR, PART NUMBER 08.804.167, IS AN ASSEMBLY CREATED WITH SUBCOMPONENTS 08.804.167.1 AND 889.961.02. COMPONENT 08.804.167.1 AND LOT NUMBER 5045135 HAD NO NON-CONFORMANCE REPORTS. MATERIAL 41019, LOT # 5011610 FROM WHICH THESE PARTS WERE MADE HAD NO NON-CONFORMANCE REPORTS AND CERTIFICATES WERE FOUND TO BE IN ORDER. SUBCOMPONENT WITH PART NUMBER 889.961.02 AND LOT NUMBER 5084678 HAD NO NON-CONFORMANCE REPORTS. MATERIAL 21038, LOT # 4924496 FROM WHICH COMPONENTS 889.961.02 WAS MADE HAD NO NON-CONFORMANCE REPORTS AND CERTIFICATES WERE FOUND TO BE IN ORDER. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE ABOVE CAGE WITH THE STANDARD IMPLANT HOLDER THE CAGE BROKE. A NEW TRAVIOS CAGE WAS IMPLANTED ON A UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    DURING THE IMPLANTATION WITH THE STANDARD IMPLANT HOLDER AND HAMMERING ON THE HOLDER THE CAGE BROKE. THE SURGEON PICKED OUT THE PIECES OF THE BROKEN CAGE BETWEEN THE VERTEBRAL BODY. THE CAGE IS PEEK (POLYETHERETHERKETONE), SO THE SURGEON CANNOT SEE ON THE X-RAY IF HE PICKED OUT ALL OF THE PIECES OF THE BROKEN CAGE. THIS ADDED THIRTY MINUTES TO THE OPERATION TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239117 VERTEBRAL SPACER-TR 12MMX33MM 7MM HEIGHT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES ELMIRA 1595436

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR