BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER F/CERVICAL CAGES

    MDR report key: 3319511 · Received August 30, 2013

    Report

    Report Number
    8030965-2013-04732
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Date of Event
    August 2, 2013
    Report Date
    August 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WE HAVE FORWARDED THE COMPLAINED DEVICE TO THE RESPONSIBLE PRODUCT DEVELOPMENT ENGINEER FOR EVALUATION, HERE IS THE FEEDBACK: NOTE THAT THE HOLDER UNDERWENT A FUNCTIONAL TEST NO PROBLEM COULD BE DETECTED. UNFORTUNATELY, WE ARE NOT ABLE TO COMPREHEND THE MENTIONED PROBLEM, THE HOLDER IS FULLY FUNCTIONAL. WE CAN ONLY SUPPOSE THAT INADEQUATE HANDLING MAY HAVE CAUSED THIS PROBLEM. THE PRESENT HOLDER WAS ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION (MANUFACTURED IN APRIL 2012). NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A CERVICAL DISC HERNIA. THE SURGEON REQUIRED THE TRIAL IMPLANT FOR THE SYNCAGE-C. THE SCRUB NURSE MOUNTED THE TRIAL IMPLANT (H4.5 MM) ON THE HOLDER AND THE SURGEON TRIED TO FIT IT TO THE SPACE. IT DID NOT FIT TIGHTLY, SO THE SURGEON REQUIRED THE SIZE-UP TRIAL IMPLANT. THE SALES REP SUGGESTED THE SCRUB NURSE TO REMOVE THE TRIAL IMPLANT (H 4.5 MM) AND REPLACE THE TRIAL IMPLANT (H 5.5 MM). SHE COULD REMOVE IT SMOOTHLY, HOWEVER SHE COMPLAINED SHE COULD NOT SCREW THE HOLDER TO THE TRIAL IMPLANT (H 5.5 MM). THE SURGEON TRIED TO SCREW IT BY HIMSELF, HOWEVER HE COULD NOT. HE USED THE LONGNOSE PLIERS TO DO SO, HOWEVER IT DID NOT WORK. THE SPACE LOOKED FITTED WITH H 7.0 MM, SO THE SALES REP SUGGESTED THE SIDE-UP. FINALLY, THE SURGEON DECIDED TO USE A H 7.0 MM AND FINISHED THE OPERATION. AFTER THE OPERATION, THE SALES REP TRIED TO SCREW THE HOLDER, BUT COULD NOT. HE APOLOGIZED TO THE SURGEON AND PROMISED THE INVESTIGATION REPORT TO HIM LATER. THE HOSPITAL STAFF WASHED, STERILIZED AND DRIED THE PRODUCT. THE SALES STAFF CHECKED IT AFTER RECEIVING THE WASHED PRODUCT. FORCE WAS APPLIED TO THE DIAL PART, AND THE DIAL COULD MOVE A LITTLE. (B)(4). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430996 HOLDER F/CERVICAL CAGES HTD SYNTHES GMBH 7844663

    Patients

    Seq Age Sex Outcome Treatment
    1