BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT FUSION CAGE HOLDER W/COMPR-INSER

    MDR report key: 3960975 · Received July 28, 2014

    Report

    Report Number
    3003875359-2014-10222
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT INVESTIGATION REPORTED USER TECHNIQUE AND THE DESIGN OF THE PRODUCT HAVE AN INFLUENCE ON THE PRODUCT PERFORMANCE. DUE TO THE FACT THAT NO PART WAS AVAILABLE FOR INVESTIGATION NO FURTHER INVESTIGATION COULD BE COMPLETED. 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: AN INVESTIGATION SUMMARY WAS PERFORMED ON THE FOLLOWING. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: FUSION CAGE HOLDERS FOR INVESTIGATION. ARTICLE 389.024 WITH LOT NUMBER 2025643 IS WORKING LIKE INTENDED AND WAS MANUFACTURED ACCORDING TO OUR SPECIFICATIONS. MANUFACTURING INVESTIGATION: SLEEVE (SUB-COMPONENT (B)(4)) FROM CAGE HOLDER WAS LOOSE. DURING MANUFACTURING INVESTIGATION: ALL RELEVANT AND SIGNIFICANT DIMENSIONAL CHARACTERISTICS FROM SUB-COMPONENTS (B)(4) (SLEEVE), (B)(4) (HOLDING TUBE), (B)(4) (SECURE CLIP) WERE MEASURED. ALL MEASURED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. PRODUCT DEVELOPMENT EVALUATION: DURING THE PROCESSING OF THE COMPLAINT A DESIGN FEATURE THAT WAS NOT CAUSE OF THE COMPLAINT WAS RECOGNIZED. ALL THE REQUIRED DRAWINGS HAVE TO BE CHANGED. THE MANUFACTURING DOCUMENTS, WORK ORDERS AND WORK INSTRUCTIONS FOR ASSEMBLING NEED TO BE CHANGED. CONCLUSION: DURING MANUFACTURING INVESTIGATION ALL RELEVANT AND SIGNIFICANT DIMENSIONAL CHARACTERISTICS FROM SUB-COMPONENTS (B)(4) (SLEEVE), (B)(4) (HOLDING TUBE), (B)(4) (SECURE CLIP) WERE MEASURED. ALL MEASURED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. 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

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED (MIA). THE REPORT INDICATES THAT: DURING THE MANUFACTURING INVESTIGATION, ALL RELEVANT AND SIGNIFICANT DIMENSIONAL CHARACTERISTICS FROM SUB-COMPONENTS 50124174 (SLEEVE), 50124172 (HOLDING TUBE), AND 50108736 (SECURE CLIP) WERE MEASURED. ALL MEASURED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. 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

    TWO PARTS 389.024 WERE RECEIVED (LOT 3792927 AND 2025643). THEY WERE ASSEMBLED WITH SLIGHT WEAR AND TEAR. LOT 3792927: NO ADHESIVE CONNECTION IN M6 BETWEEN THREAD SHAFT AND SCREW NUT. PART CAN ROTATE FREELY AND CAN BE REMOVED. LOT 2025643: NO MALFUNCTION DETECTED. IMPLANT CAN BE MOUNTED AND DISMOUNTED CORRECTLY WHEN TESTED WITH DEMO-IMPLANT IN RESEARCH AND DEVELOPMENT. CIRCLIP LOOKS DIFFERENT THAN ON ACTUAL DRAWING. 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: IT WAS REPORTED DURING SURGERY TWO DIFFERENT IMPLANT HOLDERS WOULD NOT HOLD THE CAGES SECURELY. IT WAS REPORTED THERE WAS SOME SURGICAL DELAY THE EXACT AMOUNT OF TIME IS UNKNOWN, THERE WAS REPORTED TO BE NO PATIENT HARM THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439246 CONTACT FUSION CAGE HOLDER W/COMPR-INSER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 3792927

    Patients

    Seq Age Sex Outcome Treatment
    1