BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8621013 · Received May 17, 2019

    Report

    Report Number
    8030965-2019-64118
    Event Type
    Injury
    Date Received
    May 17, 2019
    Report Date
    April 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #: THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE AVAILABLE FOR EVALUATION: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA/510K: THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATED BY MFR, MANUFACTURE DATE: PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: VERHEYDEN, A.P. ET AL (2002), ENDOSCOPICALLY ASSISTED MINIMALLY INVASIVE RECONSTRUCTION OF THE ANTERIOR THORACOLUMBAR SPINE IN PRONE POSITION, PAGES 1-8, SOURCE OF INFORMATION FROM DOI: 10.1007/S00113-002-0436-1 (GERMANY). THE AIM OF THIS STUDY IS TO PRESENT THE ADVANTAGES OF OPERATING IN THE PRONE POSITION WHICH MADE THIS TECHNIQUE AN OPPORTUNITY TO HAVE SIMULTANEOUS ANTERIOR AND POSTERIOR ACCESS TO THE SPINAL CORD. BETWEEN JULY 1999 TO MAY 2001, A TOTAL OF 42 PATIENTS (25 MALE AND 17 FEMALE) UNDERWENT SURGERY TO RECONSTRUCT THE ANTERIOR SPINAL CORD IN THE PRONE POSITION USING A RETRACTOR SYSTEM (SYNTHFRAME, SYNTHES). THE ANTERIOR INSTRUMENTATION FOR COMBINED POSTERIOR-ANTERIOR PROCEDURES USED A STABLE ANGLE SINGLE ROD SYSTEM IN 20 CASES - 14 TIMES WITH USS PEDICLE SCREWS (SYNTHES), 5 TIMES WITH VENTROFIX (SYNTHES), ONCE WITH KANEDA SR (DEPUY) AS SINGLE ROD AND TWICE AS DUAL ROD INSTRUMENTATION. SIX CASES WITH COMBINED PROCEDURES DID NOT USE ANY ANTERIOR INSTRUMENTATION. THE ISOLATED ANTERIOR ACCESS USED A STABLE ANGLE DUAL ROD SYSTEM WITH KANEDA SR (DEPUY) IN 12 CASES AND INSTRUMENTATION WITH VENTROFIX (SYNTHES) IN TWO CASES. THE POSTERIOR INSTRUMENTATION WAS PERFORMED ON 19 PATIENTS WITH USS PEDICLE SCREWS (SYNTHES), 8 PATIENTS WITH SCHANZ SCREWS (SYNTHES). THE REST OF THE PATIENTS USED A COMPETITOR¿S DEVICE. THE AVERAGE AGE WAS 41.9 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENT 16: A (B)(6) MALE PATIENT HAD RECIDIVIST PNEUMOTHORAX FROM THE INAPPROPRIATE REMOVAL OF THE THORAX DRAIN WHICH WAS TREATED WITH THE APPLICATION OF ANOTHER THORAX DRAIN. PATIENT 18: A (B)(6) MALE PATIENT HAD TRANSIENT INTERCOSTAL NEURALGIA. THIS REPORT IS FOR AN UNKNOWN SYNTHES SCHANZ SCREWS. IT CAPTURES THE REPORTED EVENT OF A (B)(6) MALE PATIENT HAD TRANSIENT INTERCOSTAL NEURALGIA. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414113 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention