BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 7450563 · Received April 23, 2018

    Report

    Report Number
    8030965-2018-53292
    Event Type
    Injury
    Date Received
    April 23, 2018
    Report Date
    April 3, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR UNKNOWN QUANTITY OF UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DATES OF IMPLANT AND EXPLANT ARE UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER CONTACT NUMBER WAS NOT PROVIDED. THIS REPORT IS FOR UNKNOWN QUANTITY OF UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SUNG, H., HO, Y., (2018), COMPARISON AMONG PERFECT-C®, ZERO-P®, AND PLATES WITH A CAGE IN SINGLE-LEVEL CERVICAL DEGENERATIVE DISC DISEASE, NOH AND ZHANG BMC MUSCULOSKELETAL DISORDERS, VOLUME 19, NUMBER 33, PAGES 1-10 (KOREA) THE OBJECTIVE OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE CLINICAL AND RADIOLOGICAL RESULTS OF PATIENTS WHO RECEIVED A PERFECT-C IMPLANT, A ZERO-P IMPLANT, OR A TITANIUM PLATE WITH A PEEK CAGE FOR THE TREATMENT OF CERVICAL DEGENERATIVE DISC DISEASE BETWEEN JANUARY 2012 AND MARCH 2016. THERE WERE 148 PATIENTS WITH SINGLE-LEVEL DEGENERATIVE CERVICAL DISC DISEASE WHO WERE SUBJECTED TO ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THIRTY-SIX (36) PATIENTS (11 FEMALE, 25 MALE, WITH MEAN AGE OF 55.64) RECEIVED AN UNKNOWN SYNTHES ZERO-P IMPLANT. THE PATIENTS WERE PLACED UNDER GENERAL ANESTHESIA. FOUR SCREWS WERE IMPLANTED THROUGH THE ANTERIOR PORTION OF THE CAGE TO SUPPORT STABILIZATION. POSTOPERATIVE FOLLOW-UP WAS DONE IN 1 TO 6 MONTHS WITH AN AVERAGE OF 6 YEARS. COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT EXHIBITED DYSPHAGIA 1 MONTH AFTER THE OPERATION. NINE PATIENTS HAD REPORTED SUBSIDENCE. THIS REPORT IS FOR UNKNOWN QUANTITY OF UNKNOWN SCREWS. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294460 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention