BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY RETAINER

    MDR report key: 5154333 · Received October 15, 2015

    Report

    Report Number
    1719045-2015-10677
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    October 5, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. UNKNOWN WHEN DEVICE ACTUALLY BROKE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE SERVICE & REPAIR HISTORY HAS BEEN REQUESTED. 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 INVESTIGATION SUMMARY ¿ A VERTEBRAL BODY RETAINER (03.820.111 LOT T924072) WAS RECEIVED WITH THE LASER WELDS ON THE HINGE BROKEN ON THE ARM. THE INSTRUMENT WAS RECEIVED DISASSEMBLED WITH THE COMPRESSION RATCHET, BAR, AND THUMB SCREW COMPONENTS NOT BEING RETURNED. THE DAMAGE TO THE LASER WELDS MAY HAVE OCCURRED DURING THE PRIOR PROCEDURE DUE TO MISHANDLING OR EXCESSIVE FORCE. THE COMPLAINT IS CONFIRMED. THE VERTEBRAL BODY RETAINER (03.820.111) IS A COMPONENT OF THE PRODISC-C INSTRUMENT AND IMPLANT SET (01.820.003). THE PRODISC-C SYSTEM IS USED TO REPLACE A DISEASED AND/OR DEGENERATED INTERVERTEBRAL DISC OF THE CERVICAL SPINE. THE VERTEBRAL BODY RETAINER IS SPECIFICALLY USED TO APPLY THE INITIAL PREDISCTRACTION TO THE DISC SPACE TO PERFORM THE PRELIMINARY DISCECTOMY, AND MAINTAIN THE VERTEBRAL BODY SPACING FOR TRIAL SPACING, KEEL PREPARATION AND IMPLANT INSERTION. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE DISTAL END OF THE CONNECTOR SLIDES INTO THE PROXIMAL END OF THE RETAINER ARM AND IS AFFIXED WITH A DOWEL PIN. THE PIN IS LASER WELDED TO THE RETAINER ARM TWICE ON EACH SIDE. EVIDENCE OF LASER WELDS IS PRESENT ON THE RETAINER ARM IN A MANNER CONSISTENT WITH THE DRAWING NOTES. EXCESSIVE FORCE OR WEAR MAY HAVE CAUSED THE WELDS TO BREAK AND THE PIN TO COME LOOSE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. 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

    SERVICE HISTORY REVIEW: PART NO: 03.820.111, SERIAL/LOT NO: (B)(4): NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 08OCTOBER2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE PIN CAME OUT OF THE JOINT. THE REPAIR TECHNICIAN REPORTED THE PIN HOLDING THE TWO PARTS TOGETHER WAS MISSING. WORN OUT PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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

    REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PIN OF A VERTEBRAL BODY RETAINER CAME OUT OF THE INSTRUMENT JOINT. THIS WAS DISCOVERED WHEN INSTRUMENT WAS BEING CLEANED IN CENTRAL STERILE REPROCESSING (CSR). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685045 VERTEBRAL BODY RETAINER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES TUTTLINGEN 5894049

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R