BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS

    MDR report key: 8978046 · Received September 9, 2019

    Report

    Report Number
    8030965-2019-68138
    Event Type
    Injury
    Date Received
    September 9, 2019
    Report Date
    August 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS / UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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: YUAN, W. ET AL. (2000), ANTERIOR CORPECTOMY COMBINED WITH CERVICAL SPINE LOCKING PLATE FOR TREATMENT OF MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY, CHINESE JOURNAL OF SURGERY, VOL. 38, NO. 3, PAGES 182-186, (CHINA). THE OBJECTIVE OF THIS STUDY IS TO STUDY THE VALUE OF CERVICAL SPINE LOCKING PLATE (CSLP) COMBINED WITH ANTERIOR CORPECTOMY IN TREATING MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY (CSM). FROM JULY 1995 TO NOVEMBER 1998, A TOTAL OF 55 PATIENTS (36 MALES AND 19 FEMALES) WITH A MEAN AGE OF 51.5 YEARS (RANGE 48-72 YEARS) WERE TREATED WITH AN UNKNOWN CERVICAL SPINE LOCKING PLATE (CSLP). THE FOLLOW-UP TIME WAS 18 TO 40 MONTHS, WITH A MEAN OF 26 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT DIED OF LIVER CANCER AFTER SURGERY. 1 PATIENT HAD AN INCISION HEMATOMA OF THE NECK AFTER SURGERY AND THE SYMPTOMS IMPROVED AFTER THE DRAINAGE WAS ENLARGED. 2 PATIENTS HA TRANSIENT HOARSENESS WHICH RETURNED TO NORMAL AFTER 3 TO 7 DAYS OF SYMPTOMATIC TREATMENT. THIS REPORT IS FOR AN UNKNOWN SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). IT CAPTURES THE REPORTED ADVERSE EVENT OF INCISION HEMATOMA. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768990 UNK - SCREWS SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention