BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALSTRUX (TRICALCIUM PHOSPHATE)

    MDR report key: 2982188 · Received December 15, 2006

    Report

    Report Number
    1224732-2006-00042
    Event Type
    Injury
    Date Received
    December 15, 2006
    Date of Event
    October 31, 2006
    Report Date
    December 8, 2006
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE REPORT 1224732-2006-00043 AND 00044.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT (B)(6) MALE WHO WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT REC'D 1 UNIT OF OP-1 PUTTY, 2 UNITS OF CALSTRUX, AUTOGRAFT, ALLOGRAFT AND HARDWARE (NOT SPECIFIED) AS PART OF A LUMBAR FUSION ON (B)(6) 2006 WAS HOSPITALIZED ON (B)(6) 2006 WITH A (B)(6) WOUND INFECTION. THE INFECTION EXTENDED BELOW THE FASCIAL PLANE. TREATMENT INCLUDED SURGICAL DEBRIDEMENT AND ANTIBIOTICS (NOT SPECIFIED). TESTING INCLUDED A WOUND CULTURE OBTAINED DURING THE SECOND SURGERY WHICH REVEALED HEAVY GROWTH OF STAPHYLOCOCCUS AUREUS. OUTCOME IS UNK. CAUSALITY WAS REPORTED A UNK. THE RPTR PREVIOUSLY SUBMITTED THIS CASE TO THE FDA ((B)(4)) BECAUSE IT WAS THOUGH THAT OP-1 PUTTY WAS A HUMAN TISSUE. ADD'L INFO WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALSTRUX (TRICALCIUM PHOSPHATE) IMPLANT MPY STRYKER BIOTECH NA TUBN014

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R