BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11921896 · Received June 2, 2021

    Report

    Report Number
    1526439-2021-01085
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 5, 2009
    Report Date
    May 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/SPACER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BARBAGALLO GMV ET AL. (2009), EARLY RESULTS AND REVIEW OF THE LITERATURE OF A NOVEL HYBRID SURGICAL TECHNIQUE COMBINING CERVICAL ARTHRODESIS AND DISC ARTHROPLASTY FOR TREATING MULTILEVEL DEGENERATIVE DISC DISEASE: OPPOSITE OR COMPLEMENTARY TECHNIQUES?, EUR SPINE J, VOLUME 18 (SUPPL 1), PAGES S29-S39 (ITALY). THIS STUDY PRESENTS A DIFFERENT CONCEPT IN THE MANAGEMENT OF CERVICAL, SYMPTOMATIC, MULTIPLE LEVEL DEGENERATIVE DISC DISEASE (DDD). THE ACCURACY, EFFICACY AND SAFETY OF A HYBRID, SINGLE-STAGE, TECHNIQUE COUPLING TOTAL DISC REPLACEMENT (TDR) AND ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WERE ANALYSED, ACCORDING TO THE PECULIARITY OF THE DISEASE AT EACH LEVEL, IN ORDER TO RESTORE OR MAINTAIN MOTION WHERE APPROPRIATE AND PROMOTE INTERVERTEBRAL FUSION OF MOST DEGENERATED LEVELS. FROM NOVEMBER 2004 TO MARCH 2007, 24 PATIENTS (15 MALES) RANGING IN AGE FROM 35 TO 65 YEARS (MEAN AGE 46.7 YEARS), WITH 2- TO 4-LEVEL SYMPTOMATIC DDD, CAUSING ANTERIOR NEURAL COMPRESSION LEADING TO RADICULOPATHY AND/OR MYELOPATHY (IN 14 PATIENTS) ASSOCIATED IN ALL BUT SIX WITH NECK PAIN, WERE OFFERED SURGERY USING THE HYBRID, SINGLE STAGE, FUSION¿NONFUSION TECHNIQUE AND WERE INCLUDED IN THE STUDY. PATIENTS WERE IMPLANTED WITH DIFFERENT COMBINATIONS OF DISC PROSTHESIS OR INTERVERTEBRAL CAGES ACCORDING TO SURGICAL FINDINGS. A TOTAL OF 59 DEVICES WERE IMPLANTED WHICH INCLUDED THE 27 UNKNOWN DEPUY SPINE CARBON FIBER REINFORCED POLYMER (CFRP) CAGE AND THE REST WERE COMPETITORS¿ DEVICES. ALL CAGES WERE FILLED IN WITH A COMPETITOR¿S DEMINERALIZED BONE MATRIX. ALL PATIENTS WERE MOBILIZED THE DAY AFTER SURGERY AND DISCHARGED HOME 48¿72 H POST-SURGERY, AFTER BEING ADVISED TO WEAR A SOFT COLLAR FOR A MONTH. CLINICAL AND RADIOLOGICAL OUTCOME MEASURES WERE COLLECTED 6 WEEKS, 3, 6, 12, 18 AND 24 MONTHS POSTOPERATIVELY, AND THEN AT REGULAR INTERVALS. FOLLOW-UP RANGED BETWEEN 12 AND 40 MONTHS (MEAN 23.8 MONTHS). COMPLICATIONS WERE REPORTED AS FOLLOWS: CASE 1, A (B)(6) YEAR-OLD MALE PATIENT WHO WAS IMPLANTED WITH A COMPETITOR¿S PROSTHESES AT C4/C5, C5/C6 AND A CFRP CAGE AT C6/C7 HAD A MCAFEE GRADE 2 HETEROTROPIC OSSIFICATION AT C4/ C5 AND C5/C6 AT 12-MONTH FOLLOW-UP. THIS PROGRESSED TO A COMPLETE FUSION (MCAFEE GRADE 4) AT C4/C5 AND TO A FUSION SIGNIFICANTLY IMPAIRING MOVEMENT (MCAFEE GRADE 3) AT C5/C6 6 MONTHS LATER. A DIFFUSE HETEROTOPIC OSSIFICATION AT C4/C5 AND C5/C6 WAS SHOWN ON A LATERAL X-RAY AT 18-MONTH-FOLLOW-UP. 1 PATIENT HAD GRADE 2 HETEROTROPIC OSSIFICATION. THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE CARBON FIBER REINFORCED POLYMER (CFRP) CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820070 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1