BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

    MDR report key: 1627906 · Received March 9, 2010

    Report

    Report Number
    1224732-2009-00007
    Event Type
    Other
    Date Received
    March 9, 2010
    Report Date
    February 26, 2010
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SOURCE OF REPORT (LITERATURE) SEQ NO.:1. AUTHOR: DR. EKROL INGRI. JOURNAL TITLE: INJURY, INT. J. CARE INJURED. YEAR: 2008. PAGE NUMBER: FROM S73 TO S82.

    Description of Event or Problem · 1

    A SEARCH OF THE SCIENTIFIC LITERATURE IDENTIFIED AN ARTICLE (EKROL, I, ET AL. A COMPARISON OF RHBMP-7 (OP-1) AND AUTOGENOUS GRAFT FOR METAPHYSEAL DEFECTS AFTER OSTEOTOMY OF THE DISTAL RADIUS) PUBLISHED IN INJURY, INT. J. CARE INJURED (2008), WHICH DESCRIBED ADVERSE EVENTS EXPERIENCED PTS WHO RECEIVED RHBMP-7 BETWEEN (B)(6) 1999 AND (B)(6) 2002 AS PART OF A CLINICAL STUDY. A (B)(6), FEMALE, RECEIVED RHBMP-7 AS PART OF A DISTAL RADIAL OSTEOTOMY AND WAS REPORTED TO HAVE PRESENTED WITH CARPAL AND DISTAL RADIO=ULNAR JOINT PAIN AND STIFFNESS ASSOCIATED WITH CARPAL MAL-ALIGNMENT. SHE HAD THE OSTEOTOMY PROCEDURE 30 WEEKS FOLLOWING HER INJURY AND POST-OPERATIVELY HEALED BY EIGHT WEEKS WITH A DORSAL DEFECT WHICH PERSISTED AT ONE YEAR. THE PT WAS REPORTED TO HAVE DEVELOPED EXTRA-OSSEOUS BONE FORMATION DORSALLY AND PROXIMAL TO THE OSTEOTOMY AS EVIDENCED BY A RADIOGRAPH. THIS WAS REPORTED TO HAVE NO EFFECT ON WRIST OR HAND FUNCTION AND REQUIRED NO INTERVENTION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO DIRECTLY FROM THE AUTHORS REGARDING THE REPORTED EVENT. THIS INCLUDED REQUESTS FOR MORE SPECIFIC INFO ABOUT THE PRODUCT(S) UTILIZED AND CLINICAL DETAILS FOR THE PTS TREATED. LETTERS WERE SENT TO THE AUTHOR ON (B)(6) 2009, (B)(6) 2009, (B)(6) 2009 AND (B)(6) 2009, HOWEVER, NO FURTHER INFO HAS BEEN RECEIVED. ON (B)(6) 2010: INITIALLY, PER STRYKER BIOTECH MEDICAL REVIEW, THERE WAS NO INFO TO SUGGEST THAT THERE WERE DEVICE-RELATED ADVERSE CONSEQUENCES TO A PT OR USER. THE DEVICE DID NOT MALFUNCTION IN A WAY TO CONTRIBUTE TO AN INJURY TO A PT OR USER. THE SURGICAL OUTCOME AS DESCRIBED BY THE AUTHORS IN THIS CASE IS CONSISTENT WITH KNOWN ALBEIT LESS THAN IDEAL CLINICAL RESULTS ASSOCIATED WITH SIMILAR INTERVENTIONS COMPLETED WITHOUT THE USE OF A BONE MORPHOGENETIC PROTEIN PRODUCT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other