BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 7135415 · Received December 20, 2017

    Report

    Report Number
    8030965-2017-50883
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    November 22, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTY-FIVE (55) PATIENTS (60% MALE, MEAN AGE 42.4+ 1.4, BMI 26.2+ 1.0 KG/M) WHO HAD SINGLE-LEVEL TOTAL DISC REPLACEMENT. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN PRODISC C IMPLANT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT IS NOT KNOWN EXPLANT OF DEVICE WAS NOT REPORTED. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (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. ATTACHMENT: [(B)(4) LITERATURE ARTICLE 21NOV2017.PDF]

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CHIN, K; ET AL (2017) CLINICAL OUTCOMES OF OUTPATIENT CERVICAL TOTAL DISC REPLACEMENT COMPARED WITH OUTPATIENT ANTERIOR CERVICAL DISCECTOMY AND FUSION. SPINE JOURNAL, 42:10, E567-E574. (USA/JAMAICA) THIS IS A RETROSPECTIVE STUDY FROM JUNE 201 TO JUNE 2015 WITH 110 PATIENTS; GROUP 1- 55 PATIENTS (60% MALE, MEAN AGE 42.4+ 1.4, BMI 26.2+ 1.0 KG/M) WHO HAD SINGLE-LEVEL TOTAL DISC REPLACEMENT (TDR) WITH PRODISC-C; SYNTHES INC., (B)(4)) IN AN OUTPATIENT SETTING AND 55 PATIENTS (57% MALE, MEAN AGE 51.5+1.2, BMI 23.3+1.5 KG/M). GROUP 2 WHO UNDERWENT SINGLE-LEVEL ACDF (ARENA-C; SPINE FRONTIER INC. (B)(4)) IN AN OUTPATIENT SETTING; FUSION WAS REINFORCED WITH AN ANTERIOR CERVICAL PLATE (ACP) (INSET; SPINE FRONTIER INC., (B)(4)). ALL OPERATIONS WERE PERFORMED BY A SINGLE SURGEON, IN AN AMBULATORY SURGERY CENTER (ASC). PATIENTS WERE ONLY CONSIDERED FOR SURGERY AFTER FAILED CONSERVATIVE MANAGEMENT FOR AT LEAST 6 WEEKS. INDICATIONS FOR TDR SURGERY INCLUDED SYMPTOMATIC, SPONTANEOUS/DEGENERATIVE, OR TRAUMATIC HERNIATED CERVICAL NUCLEI PULPOSUS WITH OR WITHOUT RADICULOPATHY AND CERVICAL DEGENERATIVE DISC DISEASE (DDD) WITHOUT POSTERIOR COLUMN INSTABILITY. INDICATIONS FOR ACDF SURGERY INCLUDED CERVICAL SPONDYLOSIS, STENOSING HERNIATED DISCS, DDD WITH INSTABILITY AND FACET ARTHRITIS, TROPISM, OR FACETOGENIC PAIN. ALL PATIENTS WERE DISCHARGED WITHIN 2 TO 4 HOURS OF COMPLETING SURGERY AFTER BEING DEEMED ORIENTED AND NEUROLOGICALLY INTACT. TWO PATIENTS IN GROUP 1 EXPERIENCED DYSPHAGIA AND 4 PATIENTS IN GROUP 2. THIS REPORT IS FOR 2 UNKNOWN PATIENTS IN GROUP 1 WHO EXPERIENCED DYSPHAGIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913452 PROSTHESIS, INTERVERTEBRAL DISC MJO OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention