BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T

    MDR report key: 3183021 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00968
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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 RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE PEDICLE SCREW HAS INDEED COME OFF. UNFORTUNATELY WE ARE NOT ABLE UNDERSTAND HOW THIS COULD HAPPEN. THEREFORE WE ARE NOT ABLE TO ELABORATE THE EXACT REASON WHICH HAS LED TO THIS PHENOMENON.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. CORRECTED DATA/ADDITIONAL INFORMATION: THIS REPORT, MFR# 2530088-2013-00968 WAS FILED IN ERROR. THIS IS A DUPLICATE REPORT TO MFR# 8030965-2011-00534. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD BECAME DETACHED FROM THE SCREW. PANGEA EXISTING L2-S1 IMPLANTED 12 MONTHS EARLIER. PLAN IS TO EXTEND CONSTRUCT TO T11 L1/2 AND L2/4 PLIF. ORIGINAL CONSTRUCT WAS EXPOSED WITH CROSSLINK, LOCKING CAPS AND RODS REMOVED. ALL SCREWS WERE FIRMLY FIXED. ONCE ROD WAS REMOVED, IT WAS NOTICED THAT THE HEAD OF THE L2 SCREW ON THE RIGHT, HAD BECOME DETACHED FROM THE SCREW. BOTH HEAD AND SCREW WERE REMOVED AND INSPECTED. THERE APPEARED TO BE NO OBVIOUS DAMAGE. A LARGE DEGREE OF METALLOSIS WAS FOUND LOCALIZED ON THE SCREW SITE WITH BLACK, DISCOLORED SOFT TISSUE AND BONE AROUND WHERE THE HEAD SOLID IN THE PEDICLE. X-RAYS AND SCANS POST ORIGINAL OPERATION AND PRE-OPERATION DID NOT INDICATE ANY OBVIOUS SCREW MALFUNCTION. THE SCREW WAS REPLACED WITHOUT INCIDENT AND IT IS ASSESSED THAT THE PATIENT DID NOT SUFFER NOR WILL SUFFER ANY ILL EFFECTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283662 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T NKB SYNTHES BRANDYWINE 6271532

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR