BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALSTRUX (TRICALCIUM PHOSPHATE)

    MDR report key: 1414430 · Received July 13, 2009

    Report

    Report Number
    1224732-2009-00040
    Event Type
    Injury
    Date Received
    July 13, 2009
    Report Date
    July 1, 2009
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO - CALSTRUX (TRICALCIUM PHOSPHATE); IMPLANT; STRYKER BIOTECH, MODEL # NA; CATALOG # 40015; SERIAL # NA; LOT# TU07017; EXP DATE: 08/31/2009. DEVICE AVAILABLE FOR EVAL - NO.

    Description of Event or Problem · 1

    ON 21-APR-2009, STRYKER BIOTECH RECEIVED A REPORT THAT A FEMALE PT WHO RECEIVED OP-1 PUTTY IN 2007 AS PART OF A REVISION LUMBAR DECOMPRESSION AND FUSION WITH INSTRUMENTATION DEVELOPED A POSTOPERATIVE WOUND INFECTION. THE PT, WHO HAD BEEN DIAGNOSED WITH SYSTEMIC LUPUS ERYTHEMATOSUS, WAS ALSO REPORTED TO BE IMMUNOCOMPROMISED AND OSTEOPOROTIC. CONCOMITANT MEDICATIONS INCLUDED STEROIDS (NOS). THE PHYSICIAN REPORTED THAT THE INFECTION WAS SERIOUS, REQUIRING HOSPITALIZATION, AND THAT AN UNSPECIFIED SURGICAL EXPLORATION WAS PERFORMED. THE PT WAS REPORTED TO HAVE RECOVERED FROM THE EVENTS. THE PHYSICIAN STATED THAT HE DID NOT BELIEVE THE EVENTS WERE RELATED TO THE USE OF THE OP-1 PUTTY. ADDITIONAL INFO WILL BE REQUESTED. ON 01-JUL-2009: THE INITIAL INFO PROVIDED BY THE REPORTER DID NOT IDENTIFY THE CATALOG # OF THE DEVICE, BUT STATED THAT THE PT RECEIVED OP-1 PUTTY. ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE REPORTER WERE MADE ON 08-MAY-2009, 21-MAY-2009 ADN 08-JUN-2009 BUT NO ADDITIONAL INFO HAS BEEN RECEIVED. INVOICE DOCUMENTATION SUBMITTED BY THE HOSP TO STRYKER BIOTECH INDICATED THAT A PT WITH THE SAME INITIALS, GENDER, AND DATE OF PROCEDURE RECEIVED THE FOLLOWING PRODUCTS: 5 UNITS OF OP-1 PUTTY, CATALOG # 30050. IN ADDITION, INVOICE DOCUMENTATION SUBMITTED BY THE HOSP TO STRYKER BIOTECH INDICATES THAT THIS PT RECEIVED 1 UNIT OF CALSTRUX, CATALOG # 40005, AND ONE UNIT OF CALSTRUX, CATALOG # 40015. THIS MDR HAS BEEN CREATED TO CAPTURE THE CALSTRUX DEVICE USAGE. SEE MDR 1224732-2009-00024 WHICH CAPTURES THE OP-1 PUTTY DEVICE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALSTRUX (TRICALCIUM PHOSPHATE) IMPLANT MPY STRYKER BIOTECH NA TU07021

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R STEROIDS (NOS)