BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T

    MDR report key: 3172954 · Received June 17, 2013

    Report

    Report Number
    2530088-2013-00947
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    November 22, 2011
    Report Date
    November 23, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION HAS SHOWN THAT THE HEAD OF THE PEDICLE SCREW HAS INDEED COME OFF. UNFORTUNATELY, WE ARE NOT ABLE TO ELABORATE THE EXACT REASON WHICH HAS LEAD TO THIS PHENOMENON. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PEDICLE SCREW WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. REGRETTABLY, WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING THE CAUSE OF FAILURE. NEVERTHELESS, YOU MAY BE ASSURED THAT WE HAVE TAKEN NOTE OF YOUR INPUT AND THAT THE CORRESPONDING STATISTICAL DATA WILL BE KEPT UNDER TRENDING OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PANGEA SCREW FELL APART DURING SURGERY. THE SCREW DISASSEMBLED DURING THE OPERATION. THE GOLDEN INNER CUP POPPED OUT WHEN THE SCREW WAS ALREADY IMPLANTED IN THE PATIENT. THE SCREW WAS REMOVED AGAIN AND A NEW SCREW WAS IMPLANTED IN ITS PLACE. THE DAMAGED SCREW IS IN THREE PARTS, THE HEAD, THE SCREW AND THE GOLDEN TULIP. 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
    272966 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T HWC SYNTHES BRANDYWINE 6276708

    Patients

    Seq Age Sex Outcome Treatment
    1