BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM SULFATE PREFORMED PELLETS

    MDR report key: 7252177 · Received February 8, 2018

    Report

    Report Number
    8030965-2018-50960
    Event Type
    Injury
    Date Received
    February 8, 2018
    Report Date
    January 10, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THIS REPORT FOR UNKNOWN BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER; THE UDI NUMBER IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE (510K#): UNKNOWN. REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILLED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE HANKE A., BAUMLEIN M., LANG S., GUEORGUIEV B., NERLICH M., PERREN T., RILLMANN P., RYF C., MICLAU T., LOIBL M. (2017). LONG-TERM RADIOGRAPHIC APPEARANCE OF CALCIUM-PHOSPHATE SYNTHETIC BONE GRAFT AFTER SURGICAL TREATMENT OF TIBIAL PLATEAU FRACTURES. INJURY, INT. J. CARE INJURED. 48:2807-2813. (B)(6). THE PURPOSE OF THIS STUDY TO ASSESS THE LONG-TERM RESORBTION OF TWO DIFFERENT CAP SYNTHETIC BONE GRAFT PRODUCTS USED FOR OPERATIVE TREATMENT OF TREATMENT OF TIBIAL PLATEAU FRACTURES BY COMPARING THEIR RADIOGRAPHIC VISIBILITY IN A LONG-TERM FOLLOW-UP. THE STUDY INCLUDED 38 PATIENTS, 21 FEMALES AND 17 MALES, ALL WITH INTRAARTICULAR TIBIAL PLATEAU FRACTURES. NINETEEN (19) OF THE PATIENTS WERE INSERTED WITH SBG TYPE A (CHRONOS INJECT, DEPUY SYNTHES, (B)(4)), AND THE REMAINING NINETEEN (19) WERE INSERTED WITH SBG TYPE B (NORIAN SRS, DEPUY SYNTHES, (B)(4)). TWO PATIENTS (ONE WITH THE SBG A AND THE OTHER WITH SBG B) EXPERIENCED EARLY WOUND INFECTIONS IN THE FIRST MONTH FOLLOWING THE SURGERY. THE HARDWARE WAS NOT REMOVED IN EITHER CASE. (B)(4). FOUR PATIENTS ( 2 IN THE SBG A GROUP AND 2 IN THE SBG B GROUP) HAD A SUBSIDENCE GREATER THAN 2 MM. ONE PATIENT DECLARED MODERATE PAIN AND REDUCED KNEE SCORES. THREE PATIENTS WERE ASYMPTOMATIC. FOUR (4) PATIENTS WHO EXPERIENCED A SUBSIDENCE GREATER THAN 2 MM WERE: 1 FEMALE PATIENT (B)(6) (SBG A), 1 FEMALE PATIENT (B)(6) (SBG A), 1 FEMALE PATIENT (B)(6) (SBG B), 1 MALE PATIENT (B)(6) (SBG B). THIS REPORT IS FOR A PATIENT WITH THE SBG A, WHO EXPERIENCED EARLY WOUND INFECTIONS IN THE FIRST MONTH FOLLOWING THE SURGERY. THIS REPORT IS FOR UNKNOWN BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99060 FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention