BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: SPINE

    MDR report key: 9618303 · Received January 22, 2020

    Report

    Report Number
    2939274-2020-00350
    Event Type
    Injury
    Date Received
    January 22, 2020
    Report Date
    January 2, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN PLATE/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN FEBRUARY 2002 AND AUGUST 2004. 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. (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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VAIDYA, R. ET AL. (2007), COMPLICATIONS OF ANTERIOR CERVICAL DISCECTOMY AND FUSION USING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2, EUROPEAN SPINE JOURNAL, VOL. 16, PAGES 1257-1265, (USA). THE PURPOSE OF THIS STUDY IS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES AND COST DIFFERENTIAL IN PATIENTS UNDERGOING ANTERIOR CERVICAL DISCECTOMY FUSION AND INSTRUMENTATION (ACDFI) WITH RHBMP-2 (INFUSE, MEDTRONIC SOFAMOR DANEK, USA) AND PEEK CAGES WITH OUR STANDARD TREATMENT OF ALLOGRAFT SPACERS (MTF SYNTHES SPINE, USA) AND DEMINERALIZED BONE MATRIX. BETWEEN FEBRUARY 2002 AND AUGUST 2004, A TOTAL OF 46 PATIENTS UNDERWENT PRIMARY ELECTIVE ANTERIOR CERVICAL DISCECTOMY AND FUSION. ONLY 24 PATIENTS (10 MALES AND 14 FEMALES) WITH AN AVERAGE AGE OF 48 YEARS (RANGE 30-69) WERE TREATED WITH ALLOGRAFT INTERBODY SPACERS (MTF SYNTHES SPINE) WITH DEMINERALIZED BONE MATRIX SUPPLEMENTED WITH AN ANTERIOR LOCKING PLATE (CSLP-SYNTHES SPINE, USA). THE MEAN FOLLOW UP WAS 28.03 MONTHS (RANGE 16¿42). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENTS HAD AVERAGE PAIN SCORES FOR NECK PAIN OF 8.5, 5.0, 4.2, 4.3, 4.2, 3.6, AND 2.6. PATIENTS HAD AVERAGE PAIN SCORES FOR ARM PAIN OF 7.1, 3.8, 3.2, 4.0, 2.5, 2.4, AND 1.8. ALL PATIENTS HAD DISTENSION OF THE SOFT TISSUE ANTERIOR TO THE CERVICAL VERTEBRAE DURING THEIR POST OPERATIVE PERIOD. (POST OPERATIVE SWELLING ANTERIOR TO THE VERTEBRAL BODIES). 20 PATIENTS HAD DYSPHAGIA. PATIENTS REPORTED DIFFICULTY WITH SWALLOWING DURING POST-OPERATIVE PERIOD. 3 PATIENTS EXPERIENCED POST-OPERATIVE VOICE HOARSENESS. 1 PATIENT HAD REPEAT SURGERY FOR A NONUNION AT 12 MONTHS. THIS WAS CONFIRMED AT SURGERY AND TREATED WITH PLATE REMOVAL, A POSTERIOR FUSION AND INSTRUMENTATION WITH RELIEF OF SYMPTOMS AT 6 MONTHS. 1 FEMALE PATIENT WITH A 2 LEVEL FUSION WAS DIAGNOSED WITH A NONUNION AT 1 OF 4 FUSION SURFACES ON REPEAT EXPLORATION AT 12 MONTHS, AS SHE HAD ONGOING NECK PAIN AND A NONUNION WAS SUSPECTED. THIS REPORT IS FOR AN ALLOGRAFT INTERBODY SPACERS (MTF SYNTHES SPINE) AND AN ANTERIOR LOCKING PLATE (CSLP-SYNTHES SPINE, USA). THIS REPORT IS FOR ONE UNKNOWN PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78931 UNK - PLATES: SPINE PLATE, FIXATION ,BONE    HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention