BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM SULFATE PREFORMED PELLETS

    MDR report key: 5086962 · Received September 18, 2015

    Report

    Report Number
    2520274-2015-15930
    Event Type
    Injury
    Date Received
    September 18, 2015
    Report Date
    September 15, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS GERICH, T., LOBENHOFFER, P., TSCHERNE, H., WITTE, F. (2002). USE OF AN INJECTABLE CALCIUM PHOSPHATE BONE CEMENT IN THE TREATMENT OF TIBIAL PLATEAU FRACTURES: A PROSPECTIVE STUDY OF TWENTY-SIX CASES WITH TWENTY-MONTH MEAN FOLLOW-UP. JOURNAL OF ORTHOPAEDIC TRAUMA, VOL 16(3), PP: 143-149 THIS REPORT IS FOR AN UNKNOWN BONE CEMENT NORIAN SRS. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GERICH, T., LOBENHOFFER, P., TSCHERNE, H., WITTE, F. (2002). USE OF AN INJECTABLE CALCIUM PHOSPHATE BONE CEMENT IN THE TREATMENT OF TIBIAL PLATEAU FRACTURES: A PROSPECTIVE STUDY OF TWENTY-SIX CASES WITH TWENTY-MONTH MEAN FOLLOW-UP. JOURNAL OF ORTHOPAEDIC TRAUMA, VOL 16(3), PP: 143-149. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE POTENTIAL BENEFIT OF A NEW INJECTABLE MINERAL BONE CEMENT NORIAN SRS (NORIAN, CUPERTINO, CA, USA. SUPPLY: SYNTHES COMP., PAOLI, PA) FOR THE TREATMENT OF TIBIAL PLATEAU FRACTURES. TWENTY-SIX PARTICIPATED IN THIS STUDY AND WERE AVAILABLE FOR FOLLOW-UP EXAMINATIONS. ALL PATIENTS HAD SUSTAINED INTRA-ARTICULAR TIBIAL PLATEAU FRACTURE TYPES OTA B2-B3 AND C3. ALL CASES WERE FOLLOWED WITH A MEAN FOLLOW-UP TIME OF 19.7 MONTHS. ONE COMPLICATION RELATING TO THE NORIAN CEMENT INCLUDED A PATIENT (CASE 7) WHO DEVELOPED STERILE WOUND DRAINAGE. NO SPECIFIC PROBLEM WAS IDENTIFIED WHEN THE WOUND WAS REVISED. A SECOND REVISION WAS NECESSARY BECAUSE OF CONTINUOUS DRAINAGE. THIS TIME THE SUPRA-PATELLAR RECESS OF THE KNEE WAS OPENED AND TWO SMALL PIECES OF CEMENT WERE REMOVED WHICH HAD FORMED TWO LOOSE BODIES IN THE JOINT CAVITY. FURTHER HEALING WAS UNEVENTFUL. THIS REPORT IS FOR AN UNKNOWN BONE CEMENT NORIAN SRS (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619146 FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention