BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ PECTUS SUPPORT BAR

    MDR report key: 4132861 · Received October 1, 2014

    Report

    Report Number
    0001032347-2014-00336
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK972420
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ATTEMPTED TO CONTACT THE CONSULTING SURGEON INTERVIEWED IN THE ARTICLE, NO RESPONSE WAS RECEIVED. WE ARE UNABLE TO DETERMINE THE PECTUS BAR WAS MANUFACTURED BY BIOMET MICROFIXATION. THE PART NUMBER AND LOT NUMBER ARE UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED AND NO PRODUCT WAS RETURNED FOR EVALUATION. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PACKAGE INSERT FOR PECTUS STATES FRACTURE, BREAKAGE, MIGRATION, OR LOOSENING OF THE IMPLANT ARE POSSIBLE ADVERSE EFFECTS. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A NEWS PAPER ARTICLE WAS PUBLISHED DESCRIBING A PECTUS REVISION SURGERY. IT IS UNKNOWN AT THIS TIME IF THE PRODUCT WAS MANUFACTURED BY BIOMET MICROFIXATION. THE ARTICLE STATES A BAR WAS IMPLANTED ON SEPTEMBER 23, 2011 AT FREEMAN HOSPITAL IN NEWCASTLE WHEN THE PATIENT WAS (B)(6) YEARS OLD. IN FEBRUARY 2012, THE PATIENT HAD INFLAMMATION OF HIS HEART SAC, HE WAS ADMITTED TO THE HOSPITAL WITH PERITONITIS AND UNDERWENT A SECOND OPERATION TO REPOSITION THE BAR AND DRAIN THE FLUID FROM HIS HEART. THE PATIENT'S CONDITION IMPROVED AFTER THIS PROCEDURE. THEN IN SEPTEMBER 2013 THE PATIENT NOTICED HIS HEART WAS MAKING A STRANGE NOISE. THE PATIENT FOLLOWED UP WITH HIS PHYSICIAN WHO TOLD HIM THE BAR FLIPPED AROUND AND GONE INTO HIS HEART. THE PATIENT UNDERWENT AN EMERGENCY HEART BYPASS OPERATION AND THE PECTUS BAR WAS EXPLANTED. THE DATE OF THE SURGERY IS NOT REPORTED IN THE ARTICLE. THE PATIENT MADE A FULL RECOVERY. THE ARTICLE ALSO STATES "SASHA STAMENKOVIC, CONSULTANT THORACIC SURGEON AT THE FREEMAN HOSPITAL, SAID: 'MR RUSSELL HAD A ROUTINE OPERATION PLACING A RIB BAR FOR A CHEST WALL DEFORMITY IN DECEMBER 2011. 'HE WAS KEPT UNDER REVIEW AND IN SEPTEMBER 2013 UNFORTUNATELY SUCCUMBED TO A KNOWN COMPLICATION OF BAR ¿MIGRATION¿, WHEREBY THE BAR IS ENVELOPED BY THE GROWING HEART IMMEDIATELY BEHIND IT (IT IS FOR THIS REASON THAT THE BAR IS REMOVED BETWEEN TWO AND THREE YEARS POST-OPERATIVELY). "AS A RESULT OF THIS COMPLICATION HE HAD AN URGENT (NOT EMERGENCY) OPERATION TO REMOVE THE BAR WHICH TOOK PLACE FOLLOWING A MULTI-DISCIPLINARY TEAM DISCUSSION. 'AFTER SURGERY HE MADE A QUICK RECOVERY AND WAS SEEN AGAIN IN CLINIC TO MONITOR HIS PROGRESS.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612459 LORENZ PECTUS SUPPORT BAR PECTUS BAR HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R