BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: TRAUMA

    MDR report key: 10556504 · Received September 18, 2020

    Report

    Report Number
    8030965-2020-07220
    Event Type
    Injury
    Date Received
    September 18, 2020
    Report Date
    August 24, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PATIENT INVOLVED. IMPLANTATION DATE UNKNOWN. THIS REPORT IS FOR AN UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM TAIWAN REPORTS AN EVENT AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WU, P.K. ET AL. (2018), GRAFTING FOR BONE DEFECTS AFTER CURETTAGE OF BENIGN BONE TUMOR E ANALYSIS OF FACTORS INFLUENCING THE BONE HEALING, JOURNAL OF THE CHINESE MEDICAL ASSOCIATION, VOL. 81, PAGES 643-648 (TAIWAN). THE OBJECTIVE OF THIS STUDY WAS TO ASSESS THE PARAMETERS THAT COULD POTENTIALLY AFFECT THE PROGNOSIS AFTER TREATMENT, INCLUDING FACTORS RELATED TO PATIENT, TUMOR, AND TREATMENT. TWO MAJOR OUTCOMES ASSOCIATED WITH BONE RESTORATION WERE ASSESSED: THE QUALITY (RADIOGRAPHIC HEALING STATUS) AND THE EFFICIENCY (HEALING TIME) OF FINAL GRAFT INCORPORATION. BETWEEN JANUARY 2004 AND JANUARY 2014, 84 PATIENTS WITH SIMPLE BONE CYST OVER LIMBS UNDERWENT INTRALESIONAL CURETTAGE PROCEDURE FOLLOWED BY BONE GRAFTING. THERE WERE 51 MALES AND 33 FEMALES, WITH A MEAN AGE OF 27.4 (RANGE: 2-82 YEARS). THE IMPLANT USED FOR THE BONE SUBSTITUTE WAS A CHRONOS STRIP (DEPUY SYNTHES, WEST CHESTER, PA, USA). THE AVERAGE FOLLOW-UP WAS 19.6 MONTHS (RANGE: 12-63 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 25 PATIENTS HAD INCOMPLETE HEALING WITH DEFECTS (NEER CLASSIFICATION II). 6 PATIENTS HAD PERSISTENT CYST (NEER CLASSIFICATION III). 2 PATIENTS HAD TUMOR RECURRENCE BEFORE ACHIEVING A STABLE HEALING STATUS. 1 PATIENT EXPERIENCED A COMPLICATION OF FRACTURE AT THE 8TH MONTH POSTOPERATIVELY. THE TUMOR WITH AN ORIGINAL LENGTH OF 11.4 CM WAS LOCATED IN THE PROXIMAL HUMERUS. AFTER CURETTAGE, THE BONE DEFECT WAS FILLED WITH BONE SUBSTITUTE AT GRADE I AND WITHOUT A FIXATION DEVICE. THIS PATIENT THEN RECEIVED CONSERVATIVE TREATMENT, AND FRACTURE UNION OCCURRED 4 MONTHS LATER WITHOUT ANY SYMPTOMS. THIS REPORT IS FOR AN UNKNOWN SYNTHES CHRONOS STRIP (DEPUY SYNTHES, WEST CHESTER, PA, USA). THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017266 UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: TRAUMA FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention