BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPAL SPACER 10MM X 32MM 11MM HEIGHT/REVOLVE-STERILE

    MDR report key: 4120680 · Received September 26, 2014

    Report

    Report Number
    3003506883-2014-10115
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    MAX
    PMA / PMN Number
    PK072791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO NCRS. OPAL SPACER, PART NUMBER 08.803.231S, IS AN ASSEMBLY CREATED WITH RAW MATERIAL (B)(4) AND COMPONENT 889.961.04. RAW MATERIAL (B)(4) CREATED LOT NUMBER 5045135 HAD NO NCRS AND CERTIFICATES WERE FOUND TO BE CORRECT. SUBCOMPONENT WITH PART NUMBER 889.961.04 CREATED ON WORK ORDER NUMBER (B)(4) AND LOT NUMBER 7247009 HAD NO NCRS. MATERIAL (B)(4), LOT # 6671606 FROM WHICH COMPONENTS 889.961.04 WAS MADE HAD NO NCRS 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. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE COMPLAINT ARTICLE HAS SHOWN, THAT THE OPAL CAGE IS BROKEN IN TWO PIECES. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY. DHR REVIEW, MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED STATES THAT THE CAGE WAS MOUNTED ON IMPACTOR CORRECTLY. DURING IMPACTION PROCESS THE CAGE BROKE INTO 3 PIECES CLOSE TO THE IMPACTOR TIP. THE 3 PIECES WERE RETRIEVED FROM THE PATIENT. ANOTHER READILY AVAILABLE DEVICE WAS PRESENT TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT HARM. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600882 OPAL SPACER 10MM X 32MM 11MM HEIGHT/REVOLVE-STERILE INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES ELMIRA 7403128

    Patients

    Seq Age Sex Outcome Treatment
    1