BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 3373983 · Received September 27, 2013

    Report

    Report Number
    2530088-2013-01192
    Event Type
    Injury
    Date Received
    September 27, 2013
    Report Date
    September 13, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER PROVIDED. THIS DEVICE IS USED FOR TREATMENT AND NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN POLYETHYLENE INLAY OF A PRODISC-L. AS NOTED IN THE COMPLAINT DESCRIPTION ¿ADJACENT LEVEL SURGERY LEADING TO SECOND SURGERY WAS REPORTED FOR 1.9 PERCENT OF TOTAL DISC REPLACEMENT (TDR) PATIENTS¿ AND ORIGINATES FROM THE FOLLOWING JOURNAL ARTICLE: ZIGLER JE ET AL, FIVE-YEAR ADJACENT-LEVEL DEGENERATIVE CHANGES IN PATIENTS WITH SINGLE-LEVEL DISEASE TREATED USING LUMBAR TOTAL DISC REPLACEMENT WITH PRODISC-L VERSUS CIRCUMFERENTIAL FUSION, J NEUROSURG SPINE, 17:504-511, 2012. THE ARTICLE IS BASED ON 5-YEAR DATA FROM THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) CLINICAL STUDY COMPARING PRODISC-L TO CIRCUMFERENTIAL FUSION. THE CLINICAL STUDY INCLUDED 161 PATIENTS IN THE TOTAL DISC REPLACEMENT (TDR) GROUP AND 75 PATIENTS IN THE CIRCUMFERENTIAL FUSION GROUP WITH RADIOGRAPHIC FOLLOW-UP DATA 5 YEARS AFTER TREATMENT AVAILABLE FOR 123 TDR PATIENTS AND 43 FUSION PATIENTS. THE PRIMARY FAILURE MODE NOTED IN THE ARTICLE AND COMPLAINT IS ADJACENT LEVEL DEGENERATION (ALD) LEADING TO REOPERATION FOLLOWING TREATMENT WITH PRODISC-L. THE LITERATURE ARTICLE DOES NOT DISCUSS POTENTIAL CAUSES FOR THE ADJACENT SEGMENT DEGENERATION WITH PRODISC-L BUT DOES PROVIDE A COMPARISON TO THE FUSION PATIENTS IN THE CONTROL ARM OF THE STUDY. RESULTS SHOW THAT TDR PATIENTS HAVE A LOWER RATE OF ADJACENT LEVEL DEGENERATION AND A LOWER RATE OF REOPERATION AT THE ADJACENT LEVEL COMPARED TO FUSION (CONTROL PATIENTS). THE FOLLOWING DETAILS ARE TAKEN FROM THE ARTICLE AND ALSO CAPTURED IN THE OCCURRENCE JUSTIFICATION SECTION OF THE DCRM FOR LINE 330. AT 5 YEARS, NO CHANGE IN ALD WERE OBSERVED IN 108 (90.8%) OF 119 TDR PATIENTS AND 30 (71.4%) OF 42 FUSION PATIENTS. THE RATE OF RADIOGRAPHIC CHANGE IN ALD AT 5 YEARS WAS STATISTICALLY SIGNIFICANTLY GREATER IN THE FUSION GROUP (P = 0.0040, FISHER EXACT TEST). FOR PATIENTS WITH NO PREOPERATIVE ALD, NEW FINDINGS OF ALD 5 YEARS AFTER TREATMENT WERE REPORTED FOR 6.7% OF TDR PATIENTS AND 23.8% OF FUSION PATIENTS. AT 5 YEARS POSTOPERATIVELY, THERE WAS A STATISTICALLY SIGNIFICANT SPARING EFFECT ON THE RADIOGRAPHIC APPEARANCE OF ADJACENT-LEVEL DEGENERATIVE DISEASE IN PATIENTS TREATED WITH ARTHROPLASTY USING THE PRODISC-L COMPARED WITH THAT IN PATIENTS WHO HAD UNDERGONE CIRCUMFERENTIAL FUSION. ADJACENT-LEVEL SURGERY LEADING TO SECONDARY SURGERY WAS REPORTED FOR 1.9% OF TDR PATIENTS AND 4.0% OF FUSION PATIENTS (P = 0.6819). THE RECENT POST MARKET SURVEILLANCE REVIEW FOR PRODISC-L PROVIDES FURTHER ASSESSMENT OF THIS LITERATURE ARTICLE. ANY OCCURRENCE TRENDS ASSOCIATED WITH COMPLAINTS RESULTING FROM LITERATURE SOURCES ARE CAPTURED AND EVALUATED THROUGH THE POST MARKET SURVEILLANCE (PMS) PROCESS. THE PRODISC-L SYSTEM WENT THROUGH THIS PMS PROCESS IN MAY 2014, WITH THE REPORT APPROVED 8/22/2014. A LITERATURE SEARCH WAS PERFORMED FROM 01/01/2011 ¿ 01/31/2014 WHICH ENCOMPASSES THE 2012 PUBLICATION DATE OF THIS ARTICLE. THIS LITERATURE ARTICLE WAS REVIEWED BY MEDICAL AFFAIRS IN ACCORDANCE WITH THE PROCEDURE. THE DETAILED LITERATURE REVIEW IS ON FILE WITH POST MARKET SURVEILLANCE AND MEDICAL AFFAIRS DEPARTMENTS. THE OUTPUT FROM THE OVERALL LITERATURE REVIEW CAPTURED IN ATTACHMENT I OF THE PMS REPORT STATES: THE RATES REPORTED IN LITERATURE APPEAR TO BE HIGHER DUE TO SMALL SAMPLE SIZE AND FOCUSED STUDY OBJECTIVES. NO NEW SAFETY EVENTS HAVE BEEN IDENTIFIED BEYOND OUR CURRENT SAFETY PROFILE FOR PRODISC-L. LITERATURE FINDINGS WERE COMPARED TO CURRENT INSERT AND LABELING FOR PRODISC-L. ADDITIONALLY, NO UNANTICIPATED ADVERSE EVENTS OR DEVICE MALFUNCTIONS HAVE BEEN IDENTIFIED. THE ADVERSE EVENTS THAT WERE IDENTIFIED IN THE LITERATURE BUT NOT FOUND IN THE PRODISC-L IFU ARE CONSIDERED TO BE KNOWN GENERAL MEDICAL COMPLICATIONS ASSOCIATED WITH HOSPITALIZATION AND/OR SURGERY, AND ARE NOT LIKELY TO BE A DIRECT ASSOCIATION WITH THE DEVICE. BASED ON THE OVERALL LITERATURE, MEDSUN, AND MAUDE REVIEW, IT IS BELIEVED THAT THE BENEFITS OF THIS PRODUCT OUTWEIGH THE RISKS. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE RECEIVED ENTITLED: FIVE-YEAR ADJACENT-LEVEL DEGENERATIVE CHANGES IN PATIENTS WITH SINGLE-LEVEL DISEASE TREATED USING LUMBAR TOTAL DISC REPLACEMENT WITH PRODISC-L VERSUS CIRCUMFERENTIAL FUSION. JACK E. ZIGLER, M.D., JAMIESON GLENN, M.D., AND RICK B. DELAMARTER, M.D. (B)(4); CORE ORTHOPAEDIC MEDICAL CENTER, ENCINITAS; AND (B)(4). J NEUROSURG SPINE 17:504¿511, 2012. A 5-YEAR RESULTS FOR RADIOGRAPHICALLY DEMONSTRATED ADJACENT-LEVEL DEGENERATIVE CHANGES FROM A PROSPECTIVE (B)(4) STUDY IN WHICH PATIENTS WERE RANDOMIZED TO EITHER TOTAL DISC REPLACEMENT (TDR) OR CIRCUMFERENTIAL FUSION FOR SINGLE-LEVEL LUMBAR DEGENERATIVE DISC DISEASE (DDD).TWO HUNDRED THIRTY-SIX PATIENTS WITH SINGLE-LEVEL LUMBAR DDD WERE ENROLLED AND RANDOMLY ASSIGNED TO 2 TREATMENT GROUPS: 161 PATIENTS IN THE TDR GROUP WERE TREATED USING THE PRODISC-L (SYNTHES SPINE, INC.), AND 75 PATIENTS WERE TREATED WITH CIRCUMFERENTIAL FUSION. RADIOGRAPHIC FOLLOW-UP DATA 5 YEARS AFTER TREATMENT WERE AVAILABLE FOR 123 TDR PATIENTS AND 43 FUSION PATIENTS. ADJACENT-LEVEL SURGERY LEADING TO SECONDARY SURGERY WAS REPORTED FOR 1.9 PERCENT OF TDR PATIENTS AND 4 PERCENT OF FUSION PATIENTS. THE TDR PATIENTS HAD A MEAN PREOPERATIVE INDEX-LEVEL RANGE OF MOTION (ROM OF 7.3 DEGREES) THAT DECREASED SLIGHTLY (TO 6.0DEGREES) AT 5 YEARS. AT 5 YEARS AFTER THE INDEX SURGERY, PRODISC-L MAINTAINED ROM AND WAS ASSOCIATED WITH A SIGNIFICANTLY LOWER RATE ALD'S THAN IN THE PATIENTS TREATED WITH CIRCUMFERENTIAL FUSION. THROUGH 5 YEARS OF FOLLOW-UP, 3 (1.9 PERCENT) OF 161 TDR PATIENTS UNDERWENT SURGICAL PROCEDURES AT AN ADJACENT LEVEL. ONE TDR PATIENT UNDERWENT FUSION AT THE L4¿5 LEVEL AND A BILATERAL LAMINECTOMY AT L3¿4 DUE TO BACK AND LEG PAIN WITH NUMBNESS. ONE TDR PATIENT UNDERWENT FUSION AT THE L4¿S1 LEVEL 5 YEARS AFTER AN L5¿S1 INDEX SURGERY; THE TDR WAS LEFT INTACT. FIVE YEARS AFTER L5¿S1 SURGERY, THE THIRD TDR PATIENT SUFFERED A HERNIATED NUCLEUS PULPOSUS AND UNDERWENT A DISCECTOMY AT L4¿5. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN PDL. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR AN UNKNOWN POLYETHYLENE INLAY OF A PRODISC-L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490383 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention