BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALSTRUX (TRICALCIUM PHOSPHATE)

    MDR report key: 1414227 · Received July 13, 2009

    Report

    Report Number
    1224732-2009-00045
    Event Type
    Injury
    Date Received
    July 13, 2009
    Report Date
    July 13, 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

    ADD'L DEVICE INFO: ADD'L CATALOG#: 40015, LOT#: TUDN022, EXP DATE: 02/28/2007.

    Description of Event or Problem · 1

    ON 04/21/2009, STRYKER BIOTECH RECEIVED A REPORT THAT A MALE PT WHO RECEIVED OP-1 PUTTY AS PART OF A REVISION MULTILEVEL KYPHOSIS CORRECTION DEVELOPED ECTOPIC BONE WHICH WAS SUBSEQUENTLY EXCISED IN 2007. THE PHYSICIAN REPORTED THAT THE PT RECOVERED FROM THE EVENTS AND THAT THERE WERE NO CLINICAL SEQUELAE. THE PHYSICIAN REPORTED THAT THE PT HAD BEEN DIAGNOSED WITH FLATBACK SYNDROME, BUT THAT HE WAS OTHERWISE HEALTHY. IN ADDITION, THE PHYSICIAN STATED THAT HE WAS NOT CERTAIN WHETHER THE EVENTS WERE RELATED TO THE USE OF THE OP-1 PUTTY, BUT ADDED THAT HE DID NOT FEEL THAT THE EVENTS WERE SERIOUS. ADD'L INFO WILL BE REQUESTED. ON 07/01/2009: THE INITIAL INFO PROVIDED BY THE REPORTER DID NOT IDENTIFY THE CATALOG NUMBER OF THE DEVICE, BUT STATED THAT THE PT RECEIVED OP-1 PUTTY. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE REPORTER WERE MADE ON 05/08/2009, 05/21/2009, AND 06/08/2009, BUT NO ADD'L INFO HAS BEEN RECEIVED. INVOICE DOCUMENTATION SUBMITTED BY THE HOSPITAL TO STRYKER BIOTECH INDICATED THAT A PT WITH THE SAME INITIAL RESULTS, GENDER, AND DATE OF PROCEDURE RECEIVED THE FOLLOWING PRODUCTS: 4 UNITS OF OP-1 PUTTY, CATALOG NUMBER 30050. IN ADDITION, INVOICE DOCUMENTATION SUBMITTED BY THE HOSPITAL TO STRYKER BIOTECH ALSO INDICATES THAT THIS PT RECEIVED 2 UNITS OF CALSTRUX, CATALOG NUMBER 40005, AND ONE UNIT OF CALSTRUX, CATALOG NUMBER 40015. THIS MDR WAS CREATED TO CAPTURE THE CALSTRUX DEVICE USAGE. PLEASE REFER TO MDR 1224732-2009-00031, 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 TUBN013

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R