BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 & 9

    MDR report key: 3247763 · Received July 25, 2013

    Report

    Report Number
    2520274-2013-04426
    Event Type
    Injury
    Date Received
    July 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    LOT #8001151. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION WAS PERFORMED AND IT WAS REPORTED: THE DEVICE IS MANUFACTURED OUT OF TAN WHICH IS AN ACCORDING TO THE INTERNATIONAL STANDARD ISO 5832-11 APPROVED IMPLANT MATERIAL. THE DEVICE HISTORY RECORDS INDICATE THAT THIS PLATE WAS WASHED DURING THE MANUFACTURING PROCESS AS REQUIRED AND AS THIS PLATE WAS NOT SHIPPED IN A STERILE CONDITION WE EXCLUDE A MANUFACTURING FAULT IN RELATION TO THE INFECTION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED BY THE PRODUCT DEVELOPMENT ENGINEER AND IT WAS REPORTED: THE COMPLAINT DESCRIPTION INDICATED THAT THE PATIENT HAD AN EMPYEMA PRESENT IN THE CHEST CAVITY AND A SHOULDER INFECTION AT EXPLANTATION. THE IMPLANT DURATION WAS APPROXIMATELY 2 MONTHS AND THE PATIENT¿S COMPLIANCE DURING THIS TIME PERIOD IS UNKNOWN. THE SOURCE OF ANY INFECTION IS UNKNOWN. THE EXTENT THAT THE PATIENT¿S CO-MORBIDITIES CONTRIBUTED TO THIS COMPLAINT IS NOT KNOWN. THE DEVICES WERE IMPLANTED AS PART OF CHEST WALL STABILIZATION AND IT IS UNKNOWN IF THE IMPLANTATION FOLLOWED THE PROPER TECHNIQUE AS OUTLINED IN THE MATRIXRIB TECHNIQUE GUIDE (J8654-C). (B)(4) CORRECTED DATA H4: CORRECTED DEVICE MANUFACTURING DATE FROM 07/20/2013 TO 07/20/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 FOR AN INFECTION IN THE LEFT SHOULDER. UPON EXAMINATION, INFECTION WAS FOUND SURROUNDING THE PATIENT'S LEFT RIB WHERE PREVIOUS THORACOTOMY / RIB FIXATION TOOK PLACE. SURGEON REQUESTED REMOVAL OF ALL HARDWARE AND PLACEMENT OF A WOUND VAC ON AREA. DURING SURGERY ON (B)(6) 2013, THE SURGEON FOUND AN EMPYEMA PRESENT IN THE CHEST CAVITY. THE PATIENT'S CHEST WALL STABILIZATION SURGERY TOOK PLACE (B)(6) 2013. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349255 TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 & 9 HRS SYNTHES USA 8001151

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention