BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME RING CLAMP

    MDR report key: 7366769 · Received March 23, 2018

    Report

    Report Number
    8030965-2018-52368
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 20, 2018
    Report Date
    February 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819141278
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PART 387.347, LOT 8121098: RELEASE TO WAREHOUSE DATE: NOVEMBER 07, 2012. MANUFACTURING SITE: (B)(4). NO NON-CONFORMANCE REPORTS (NRCS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: WE HAVE RECEIVED THE PART FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE PART IS IN A VERY USE AND POOR CONDITION, AS THE ARTICLE IS BADLY WORN, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. FURTHERMORE THE COATING IS FADED, FROM OFTEN USE AND REPROCESSING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. NO NCRS WERE MARKED IN THE DHR DURING PRODUCTION. WE CLASSIFY THIS AS NORMAL WEAR AND TEAR/END OF LIFE AND SUCH INSTRUMENTS MUST BE REPLACED FROM TIME TO TIME. IN THIS RELATION OUR IMPORTANT INFORMATION LEAFLET CONTAINS THE FOLLOWING STATEMENT: END OF LIFE OF A DEVICE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. EVIDENCE OF DAMAGE AND WEAR ON A DEVICE MAY INCLUDE BUT IS NOT LIMITED TO CORROSION (I.E. RUST, PITTING), DISCOLORATION, EXCESSIVE SCRATCHES, FLAKING, WEAR AND CRACKS. IMPROPERLY FUNCTIONING DEVICES, DEVICES WITH UNRECOGNIZABLE MARKINGS, MISSING OR REMOVED (BUFFED OFF) PART NUMBERS, DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED. 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

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE WAS PERFORMED ON (B)(6) 2018. DURING THE ALIF PORTION OF THE PROCEDURE, THE BLUE SYNFRAME RING CLAMPS WERE NOTED TO BE LOOSE, WHICH CREATED SOME MOTION AROUND THE BLADES/RING AND CAUSED POTENTIAL RISKS DURING THE SURGERY. NO CONSEQUENCE TO PATIENT WAS REPORTED. REPORTEDLY THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYNFRAME RING CLAMP. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208726 SYNFRAME RING CLAMP MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 8121098 07611819141278

    Patients

    Seq Age Sex Outcome Treatment
    1