BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

    MDR report key: 887028 · Received July 30, 2007

    Report

    Report Number
    1224732-2007-00075
    Event Type
    Injury
    Date Received
    July 30, 2007
    Date of Event
    September 18, 2006
    Report Date
    July 30, 2007
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #FD0207002.

    Description of Event or Problem · 1

    A (B)(6) MALE ((B)(6)), ENROLLED IN STRYKER BIOTECH STUDY (B)(4) "PROSPECTIVE DATA COLLECTION FROM THE STRYKER BIOTECH PIVOTAL IDE STUDY OF OP-1 PUTTY IN UNINSTRUMENTED POSTEROLATERAL FUSIONS" WHO RECEIVED 2 UNITS OF OP-1 PUTTY AT LEVEL L3-L4 ON (B)(6) 2002 FOR A DEGENERATE LUMBAR SPONDYLOLISTHESIS WITH SPINAL STENOSIS (GRADE I) WAS HOSPITALIZED ON (B)(6) 2007 FOR SPONDYLOLISTHESIS L3-L4 AND LUMBAR STENOSIS L3-L4. TREATMENT INCLUDED AN L3 POSTERIOR REVISION DECOMPRESSION, A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L4, POSTERIOR INSTRUMENTATION FUSION AT L3-L4 WITH PEDICLE SCREWS AND A ROD, AND POSTEROLATERAL FUSION WITH MORSELLIZED LOCAL AUTOGRAFT USING FLUOROSCOPY. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2007. THE INVESTIGATOR ASSESSED THE SEVERITY AS SEVERE AND RELATED TO OP-1 PUTTY. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP-1 PUTTY (OSTEOGENIC PROTEIN 1) IMPLANT MPY STRYKER BIOTECH 30050 FD0210005

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R