BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP HOLDER FOR USS ILIOSACRAL

    MDR report key: 3083785 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11201
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 15, 2012
    Report Date
    August 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT DEVELOPMENT EVALUATION SHOWED THE CLAMP HOLDER IS DESIGNED TO THREAD INTO THE CLAMP 3H HEAD TO ALLOW INSERTION AND MANIPULATION VIA THE REDUCTION PLIERS. THIS DESIGN IS COMMON WITHIN THE USS FAMILY AND IS APPROPRIATE FOR ITS INTENDED USE. IN CONCLUSION, IT IS UNCLEAR WHAT CAUSED THE THREADED TIP TO BREAK. IT IS POSSIBLE THAT EXCESSIVE FORCES DURING SURGERY AND MANIPULATION CAUSED THE TIP TO BREAK. THIS COMPLAINT IS DEEMED INDETERMINATE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING L2 ILIUM FUSION PROCEDURE, THE PORTION OF THE INSTRUMENT THAT SCREWS INTO THE CLAMP BROKE OFF INTO THE CLAMP. THE BROKEN PORTION WAS RETRIEVED. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185448 CLAMP HOLDER FOR USS ILIOSACRAL LXH SYNTHES GMBH 3004525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR