BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUSSCR SYNAPSE Ø4.5 L28 TAN

    MDR report key: 3183628 · Received June 22, 2013

    Report

    Report Number
    2530088-2013-00963
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    June 26, 2012
    Report Date
    June 29, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. WE FORWARDED THE COMPLAINED DEVICE TO THE RESPONSIBLE PRODUCT DEVELOPMENT ENGINEER FOR EVALUATION. THE INVESTIGATION RESULTS REVEALED THAT THE POLYAXIAL HEAD HAS INDEED COME OFF THE SCREW AND THE SCREW HEAD IS BADLY DEFORMED. IT WAS OBSERVED THAT THE INNER BUSHING IS DEFORMED AS WELL. THESE DAMAGES ON THE SCREW PARTS CLEARLY INDICATE THAT FAR TOO MUCH MECHANICAL FORCE BEEN APPLIED. UNFORTUNATELY WE DID NOT RECEIVE ANY FURTHER DETAILED INFORMATION IN ORDER TO MAKE AN EXACT ASSUMPTION. NOTE THAT WE HAVE NOT HAD A SINGLE COMPLAINT WITH THIS ITEM SO FAR. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS AND NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. AS WE DID NOT RECEIVE ANY FURTHER DETAILED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    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 SCREW HEAD PULLED OUT OF THE SCREW DURING THE INSERTION OF THE SYNAPSE SCREW TO THE CERVICAL PEDICLE. THE SURGEON HAD TO PULL OUT THE REMAINING PART OF THE SCREW, THE SCREW SHAFT FROM THE PEDICLE WITH PLIERS BY TURNING. THE RETRIEVED SCREW PARTS WERE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284331 CANCELLOUSSCR SYNAPSE Ø4.5 L28 TAN KWP SYNTHES BRANDYWINE 6486992

    Patients

    Seq Age Sex Outcome Treatment
    1