BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3173075 · Received June 17, 2013

    Report

    Report Number
    2530088-2013-00939
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    December 5, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS NOT CONFIRMED AS THE MENTIONED MALFUNCTION COULD NOT BE REPRODUCED. ADDITIONAL FUNCTIONAL TESTS TEST WERE PERFORMED AND WE ARE NOT ABLE TO REPRODUCE THE COMPLAINED MALFUNCTION. 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. NO PRODUCT FAULT COULD BE DETECTED AND THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE PRESENT PEDICLE SCREWS WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. AS THE COMPLAINT CONDITION COULD NOT BE REPRODUCED THE COMPLAINT IS CONSIDERED INVALID AND A NON-ISSUE. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND BASED ON THE COMPLAINT DESCRIPTION WE CAN ONLY ASSUME THAT THE PEDICLE SCREWS WERE NOT CORRECTLY ATTACHED ONTO THE INSTRUMENT.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE PROBLEMS DURING THE INSERTION OF THE PEDICLE SCREWS. THE FIRST SCREW WOULD NOT RELEASE FROM THE PRIME LOCK MECHANISM. THE SECOND SCREW WAS IMPLANTED BUT THE PRIME LOCK MECHANISM MUST HAVE CROSS THREADED AND THEREFORE WHILE INSERTING THE SCREW, THE THREAD IN THE HEAD WAS STRIPPED. THE FINAL SCREW WAS USED BECAUSE THE HOLE HAD ALREADY BEEN MADE AND INSUFFICIENT PURCHASE WAS FOUND IN THE BONE. ONE OF THE LOCKING CAPS IS ALSO DAMAGED HOWEVER THIS IS STILL IN THE PATIENT. THE THREAD OF THE HEAD IS ALSO STRIPPED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273709 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6706173

    Patients

    Seq Age Sex Outcome Treatment
    1