BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR

    MDR report key: 2993931 · Received March 8, 2013

    Report

    Report Number
    2530088-2013-00271
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING EVALUATION FOR (B)(4), 1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR, LOT NUMBER 6940254, SHOWED THAT THE FOOTPLATE WAS IN SPECIFICATION FOR THE L1 PLATE THICKNESS, THE PLATE HOLE DIAMETERS, D1 AND THE MATERIAL, TITANIUM. THE L6, G1, L2, L3, L4,L5, D2 AND F1 DIMENSIONS ARE UNOBTAINABLE DUE TO THE DAMAGE TO THE PART OR THE ASSEMBLED CONDITION OF THE FOOTPLATE. THE PLATE IS STILL ATTACHED TO THE PLATE AND NOT BROKEN.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR PART NUMBER (B)(4), 1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR, LOT NUMBER 6940254 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PARTS FROM LOT NUMBER 6940254 WERE ALSO UNPACKED, REPACKED/RE-LABELED FOR EXPORT SHIPMENT. REPACKAGING/RE-LABELING DOES NOT AFFECT THE FUNCTION OF THE DEVICE. A REVIEW OF THE RAW MATERIAL DHR FOR LOT NUMBER 4830091 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. TWO BC DISTRACTOR BODIES ASSEMBLIES WITH UNIVERSAL JOINTS, ASSEMBLED FOOTPLATES AND ATTACHED FLEXIBLE EXTENSION ARMS WERE RETURNED. ONE OF THE RETURNED ASSEMBLIES COMPRISED ONE BC DISTRACTOR BODY 35MM; ONE 1.5MM FOOTPLATE C-TYPE; ONE 1.5MM FOOTPLATE B-TYPE BROKEN THROUGH THE SCREW HOLE CLOSEST TO THE DISTRACTOR BODY; ONE FLEXIBLE EXTENSION ARM. THE SECOND RETURNED ASSEMBLY COMPRISED ONE BC DISTRACTOR BODY 35MM LONG; ONE 1.5MM FOOTPLATE C-TYPE; ONE 1.5MM FOOTPLATE B-TYPE BROKEN THROUGH THE CHANNEL THAT GUIDES THE FOOTPLATE ALONG THE DISTRACTOR BODY; ONE FLEXIBLE EXTENSION ARM. THE FOOTPLATES ON BOTH RETURNED ASSEMBLIES WERE CUT AND BENT; THERE WERE SOME MARRING AND SURFACE SCRATCHES ACROSS EACH FOOTPLATE. THERE WAS SOME MARRING AND SURFACE SCRATCHES ON THE DISTRACTOR BODY. ALL FOOTPLATES APPEAR TO BE CUT AND CONTOURED AS DESCRIBED IN STEP 4 OF THE CMF DISTRACTION SYSTEM TECHNIQUE GUIDE; NO SEVER CONTOURS OR CUTS WERE APPARENT. THE FOOTPLATES AND THE DISTRACTOR BODY APPEARED TO BE ASSEMBLED AS DESCRIBED IN STEP 3B OF THE CMF DISTRACTION SYSTEM TECHNIQUE GUIDE; WITH THE C-TYPE FOOTPLATE ATTACHED AT THE END OF THE DISTRACTOR BODY AND THE B-TYPE FOOTPLATE ASSEMBLED ALONG THE LEAD SCREW OF THE DISTRACTOR BODY. AS DESCRIBED IN THE COMPLAINT DESCRIPTION AND SEEN ON THE ATTACHED X-RAY IMAGES, TWO DISTRACTOR ASSEMBLIES WERE IMPLANTED IN THE PATIENT, ONE ON EACH SIDE OF THE MANDIBLE. EACH DISTRACTOR ASSEMBLY WILL BE EVALUATED SEPARATELY BECAUSE THE MECHANISM OF FAILURE FOR EACH DEVICE IS DIFFERENT. FOR THE LEFT BC DISTRACTION ASSEMBLY, THE LOCATION OF THE FRACTURE ON THE FOOTPLATE IS THROUGH THE CHANNEL THAT GUIDES THE FOOTPLATE ALONG THE DISTRACTOR BODY. THIS FRACTURE WAS NOTED IN THE COMPLAINT DESCRIPTION TO HAVE BEEN CAUSED AT TIME OF REMOVAL BUT IN REVIEWING THE QUESTIONNAIRE FROM THE SURGEON AND THE X-RAY IMAGES PROVIDED, THIS STATEMENT IS NOT CORRECT; THE NOTED BREAKAGE OCCURRED AFTER SUCCESSFUL DISTRACTION DURING THE PHASE OF CONSOLIDATION - SOMETIME BEFORE (B)(6) 2013. THE FRACTURES PATTERN INDICATES THAT A TORSIONAL AND BENDING LOAD WAS APPLIED TO THE BC DISTRACTOR BODY; CAUSING THE CHANNEL IN THE FOOTPLATE TO WIDEN AND BREAK THROUGH THE CHANNEL REGION. THIS FRACTURE PATTERN WOULD BE CONSISTENT WITH THE X-RAY IMAGES PROVIDED THAT SHOW THE FOOTPLATE STILL ATTACHED TO THE BONE WITH THE BC DISTRACTOR BODY PULLED AWAY FROM THE FOOTPLATE. THE CAUSE OF THE TORSIONAL AND BENDING LOAD THAT LED TO THE NOTED FAILURE IS NOT KNOWN; THOUGH EXCESSIVE PATIENT STRAIN CAN BE APPLIED TO THE DISTRACTOR DURING ACTIVITIES THAT THE PATIENT PARTICIPATES IN SUCH AS PLAYING OR SLEEPING. THE 30 PERCENT RELAPSE NOTED IN THE COMPLAINT, CAN BE CONTRIBUTED TO THE FOOTPLATE BREAKING DURING THE CONSOLIDATION PHASE AND NOT A RESULT OF THE DISTRACTOR REVERSING. AS SEEN IN THE PROVIDED X-RAY IMAGES AND NOTES IN THE QUESTIONNAIRE, THE DISTRACTION WAS SUCCESSFULLY AND FULLY EXTENDED AT THE BEGINNING OF THE CONSOLIDATION PHASE. THE RISK ASSESSMENT FOR THIS DEVICE DOES ADDRESS THE HAZARD OF PREMATURE FOOTPLATE FAILURE ARISING FROM INADEQUATE DESIGN OR EXCESSIVE STRAIN BY THE PATIENT RESULTING IN RE-OPERATION. THE SEVERITY IT ADEQUATELY DISPOSITIONED AS A 4. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED DEVICE AS CONFORMING.

    Description of Event or Problem · 1

    THIS IS 4 OF 8 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT WAS IMPLANTED WITH TWO DISTRACTORS. ON (B)(6) 2013 THE SURGEON PERFORMED A REMOVAL OF TWO DISTRACTORS BECAUSE THEY WERE READY TO COME OUT AND NOTICED THEY WERE NOT DISTRACTING TO THE BONE. THE DISTRACTORS WERE RELAPSING AT 30 PERCENT AND NOT FUNCTIONING. AT THE TIME OF THE REMOVAL OF THE DISTRACTORS TWO OF THE FOOT PLATES BROKE. THE PROCEDURE WAS PROLONGED BY AN UNSPECIFIED AMOUNT OF TIME, TAKING LONGER THAN THE NORMAL PROCEDURE TIME. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98567 1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR MQN SYNTHES BRANDYWINE 6940254

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention