BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4768446 · Received May 13, 2015

    Report

    Report Number
    2520274-2015-13365
    Event Type
    Injury
    Date Received
    May 13, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN PRODISC C , UNKNOWN QUANTITY, UNKNOWN ITEM NUMBER AND UNKNOWN LOT NUMBER. UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE; FINOCCHIARO, FM; (2013) "TEN YEAR LUMBAR DISC ARTHROPLASTY FOLLOW UP". ITALY. EUR SPINE J (2013) 22:900-952. THIS ABSTRACT ARTICLE REPORTS COMPLICATIONS THAT WERE REPORTED IN STUDIES AT THE SPINE SURGERY UNIT, PADUA UNIVERSITY GENERAL HOSPITAL, ITALY REGARDING PROSTHETIC REPLACEMENT OF THE INTERVERTEBRAL DISC. THE ARTICLE CONTAINED INFORMATION CONCERNING 124 PATIENTS THAT HAVE GONE THROUGH ARTHROPLASTY DISC OPERATION FROM 2001 TO 2012. TWENTY ONE PATIENTS WERE TREATED WITH PRODISC C PROTHESIS. A TEN YEAR LUMBAR DISC ARTHROPLASTY STUDIED WAS CARRIED OUT AND NUMEROUS PROSTHETIC DESIGN PROPOSITIONS WERE PRESENTED WITH CLINICAL RESULTS IMPROVING OVER TIME. INDICATIONS FOR PROSTHETIC REPLACEMENT OF THE DISC ARE PRIMITIVE DISCOPATHY AND POST-DISCECTOMY DISCOPATHY ALSO WITH LOWER BACK PAIN AND INTACT POSTERIOR ELEMENTS. YOUNG ADULTS WITH SECONDARY ZYGAPOPHYSIAL ALTERATIONS FROM OSTEOARTHRITIS OR AS A RESULT OF BACK SURGERY, NO INSTABILITY, STENOSIS OR DEFORMITY, HEIGHT OF DISC 4 MM, NO DEGENERATION AT ADJACENT LEVELS. A MINIMAL DEGENERATION OF THE ADJACENT DISCS AND A MINIMAL SEGMENTAL INSTABILITY ARE TOLERATED, BUT ONLY WITHOUT ZYGAPOPHYSIAL OSTEOARTHRITIS IN ORDER TO ACHIEVE GOOD RESULTS AND TO AVOID FUSION SURGERY. TECHNIQUE RELATED COMPLICATIONS INCLUDED:1 COMMON SX ILIAC THROMBOSIS; 1 RETROGRADE EJACULATION; 1 INCISIONAL HERNIA; 1 WORSENING OF BACK PAIN -POSTERIOR STABILIZATION; 2 TRANSIENT RADICULAR DISORDERS POST-DISCECTOMY DISCOPATH; 1 ASYMMETRIC ASYMPTOMATIC POSITIONING. FOLLOW-UP COMPLICATIONS: 1 OSSIFICATION AND 1 SINKING ASYMPTOMATIC; 2 JUNCTIONAL OVERLOAD DISORDERS. REPORTABLE COMPLICATES ARE WORSENING OF BACK PAIN -POSTERIOR STABILIZATION THIS REPORT IS FOR 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC C, UNKNOWN PART NUMBER/LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312707 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention