BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNALOCK 6 HOLE STRAIGHT PLATE

    MDR report key: 4890975 · Received July 6, 2015

    Report

    Report Number
    0001032347-2015-00288
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    June 30, 2015
    Report Date
    May 18, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK110574
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT ONE OF THREE FOR THE SAME EVENT, SEE ALSO 1032347-2015-00289-1 AND 1032347-2015-00290-1. AN ADDITIONAL SCREW WAS RECEIVED FOR EVALUATION THAT WAS NOT REPORTED, SEE REPORT 1032347-2015-00418.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. FILE ONE OF THREE FOR THE SAME EVENT, SEE ALSO 1032347-2015-00289 AND 1032347-2015-00290.

    Additional Manufacturer Narrative · 1

    CORRECTIONS WERE IDENTIFIED THAT WERE NOT ENTERED IN THE SUPPLEMENTAL SUBMISSION 1032347-2015-00288-1. IMPLANT DATE WAS ADDED, (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    THE FOUR PLATES (SP-2899: STERNALOCK 6 HOLE STRAIGHT PLATE QTY 2 AND 73-1952: STERNALOCK 8 HOLE STRAIGHT PLATE QTY 2) WERE VISUALLY INSPECTED AND CONFIRMED THAT ALL FOUR PLATES ARE FRACTURED THROUGH THE MIDDLE CUT-ABLE CROSS SECTION. A REVIEW OF ALL SHIPMENTS TO THE CUSTOMER WAS DONE FOR THE TWO PLATE PARTS TO DETERMINE POSSIBLE LOTS FOR THE FRACTURED PLATES, LOT 781220 MANUFACTURE DATE 06/25/13 WAS IDENTIFIED FOR PART NUMBER SP-2899. THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND NO DISCREPANCIES OR ABNORMALITIES WERE FOUND. THE PRINTS WERE REVIEWED AND CALIPERS WERE USED TO MEASURE THE CUT-ABLE CROSS SECTIONS. ALL FOUR PLATES MEASURED WITHIN SPECIFICATION. X-RAYS TAKEN OF THE PATIENT THAT SHOWS THE PLACEMENT OF THE PLATES IDENTIFIED THAT THE PLATES WERE POSITIONED IN THE POSTERIOR CHEST WALL. THESE PLATES ARE NOT CLEARED FOR USE IN THE POSTERIOR CHEST WALL (ONLY ANTERIOR CHEST WALL). THE PACKAGE INSERT STATES: "THE BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM IS INTENDED FOR USE IN THE STABILIZATION AND FIXATION OF FRACTURES OF THE ANTERIOR CHEST WALL INCLUDING STERNAL FIXATION FOLLOWING STERNOTOMY AND STERNAL RECONSTRUCTIVE SURGICAL PROCEDURES, TO PROMOTE FUSION." THE MOST LIKELY CAUSE OF THE FRACTURE IS EXCESSIVE FORCE APPLIED TO THE PLATES AFTER IMPLANTATION DUE TO PLACEMENT OUTSIDE OF PRODUCT INDICATIONS. SUPPLEMENTAL REPORT ONE OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2015-00289-2, 1032347-2015-00290-2 AND 1032347-2015-00418-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1032347-2015-00289-3, 1032347-2015-00290-3 AND 1032347-2015-00418-2.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS FIXATED WITH FOUR (4) EIGHT HOLE PLATES ABOUT A MONTH AND A HALF AGO, THEY BEGAN EXPERIENCING SOME PAIN AND A GRINDING SENSATION. THE PHYSICIAN ORDERED AN X-RAY AND IDENTIFIED THAT ALL FOUR PLATES HAD FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO REMOVE THE FRACTURED PLATES. NO ADDITIONAL DETAILS OR OPERATIVE RECORDS HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE RECEIPT OF A LEGAL CLAIM THE PATIENT SUFFERED SEVERE AND CONSTANT RIB PAIN, SLEEP LOSS, DELAYED HEALING, AND WAS REQUIRED TO UNDERGO A SECOND SURGICAL PROCEDURE. THE PATIENT WAS DIAGNOSED WITH MULTIPLE LEFT-SIDED RIB FRACTURES AFTER BEING STRUCK BY A MOTOR VEHICLE. THE FINDINGS IN THE OPERATIVE RECORD STATE THERE WAS SIGNIFICANT ADHESIONS OF THE LUNG TO THE CHEST WALL DUE TO THE NATURE OF THE REDO SURGERY. THE FOUR PLATES WERE REMOVED AND REPLACED WITH ACUTE INNOVATIONS (AI) PLATING SYSTEM. DURING THE REVISION A FIFTH RIB FRACTURE WHICH SEEMED TO BE MORE OUT OF PLACE COMPARED TO SEVERAL MONTHS AGO WAS IDENTIFIED AND WAS ALSO PLATED WITH THE AI SYSTEM. THE OPERATIVE RECORD STATES THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437472 STERNALOCK 6 HOLE STRAIGHT PLATE BONE PLATE HRS BIOMET MICROFIXATION N/A 781220

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R