BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3255584 · Received July 31, 2013

    Report

    Report Number
    2520274-2013-04842
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 4, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE ADDED TO REPORTED EVENT. TOTAL NUMBER OF REPORTS CHANGED FROM 2 TO 3 REPORTS. DATE DEVICE RECEIVED FOR EVALUATION CORRECTED FROM (B)(4) 2013 TO (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED INTACT. THE RETAINING SLEEVES WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS AND FOR FUNCTIONING; NEITHER A PRODUCT NOR A FUNCTION FAULT COULD BE DETECTED. THE MENTIONED MALFUNCTION COULD NOT BE REPRODUCED AND THESE ARTICLES WERE FOUND TO BE IN PERFECT WORKING ORDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE HOLDING SLEEVE-LONG FOR MATRIX WAS MANUFACTURED BY AVALIGN TECHNOLOGIES - NEMCOMED. THE PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET ON 4/17/2012. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED FOR 4/13/2012. 174 PARTS WERE RELEASED TO THE WAREHOUSE ON 4/18/2012. NO NCRS 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.

    Additional Manufacturer Narrative · 1

    RECEIPT DATE OF DEVICE WAS REPORTED IN ERROR. RECEIPT DATE SHOULD BE (B)(4) 2013.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2013, ONE OF THE SCREW HEADS CAME LOOSE FROM THE BONE SCREW DURING PLACEMENT ON LEVEL L4. IT WAS ALSO REPORTED, WHEN THE SURGEON TRIED TO CHANGE THE DIRECTION OF THE SCREW, THE TIP OF THE HOLDING SLEEVE BROKE OFF. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 2 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357734 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6860569

    Patients

    Seq Age Sex Outcome Treatment
    1