BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXUR M

    MDR report key: 4308731 · Received December 9, 2014

    Report

    Report Number
    2246640-2014-00011
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 11, 2014
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MQV
    PMA / PMN Number
    K073405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND UNIT OF RESORBABLE BONE VOID FILLER WAS ALSO IMPLANTED DURING THE SAME PROCEDURE: PLEXUR M (FILLER, BONE VOID, CALCIUM COMPOUND); MODEL/CATALOG #: 6100-010; SERIAL NUMBER: (B)(4); EXP DATE: MAY 1, 2015. (B)(4). DEVICE HISTORY RECORDS FOR THE TWO SUSPECT LOTS OF PRODUCT WERE REVIEWED AND INDICATED THAT THE SUBJECT GRAFTS WERE MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED PRODUCT SPECIFICATIONS. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THESE GRAFTS. THE GRAFTS WERE TERMINALLY STERILIZED USING GAMMA RADIATION, WITHIN THE REQUIRED DOSAGE RATE, AND WERE RELEASED STERILE, AS LABELED. PRODUCT IS DESIGNED TO RESORB/REMODEL AND IS REPLACED BY HOST BONE DURING THE HEALING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A RESORBABLE BONE VOID FILLER IMPLANT FOLLOWING A RIGHT CALCANEAL FRACTURE. APPROXIMATELY 11 WEEKS POST OP, THE PATIENT BEGAN "EXHIBITING SYMPTOMS," AND ONE WEEK LATER, HE WAS READMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT A REVISION THE FOLLOWING DAY DUE TO A "SUSPECTED SURGICAL WOUND INFECTION". DURING THIS PROCEDURE, THE IMPLANT SITE WAS LAVAGED ('SURGICAL SCRUB') AND THE CALCANEUS WAS CURETTED OF "GRANULOMATOUS" MATERIAL WHICH WAS EXPLANTED AND DISCARDED. TISSUE SAMPLE AND CULTURES WERE TAKEN. IT WAS REPORTED THAT THE SURGEON FEELS THIS WAS A "REACTION" TO THE IMPLANT. PATIENT OUTCOME WAS REPORTED AS "IN RECOVERY, WITH ANTIBIOTIC MANAGEMENT" AND IN "GOOD OVERALL CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795825 PLEXUR M FILLER, BONE VOID, CALCIUM COMPOUND MQV OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) 6100-005INT

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Hospitalization| R