BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 3522817 · Received December 17, 2013

    Report

    Report Number
    2530088-2013-01343
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2013: DATE OF EVENT IS DATE OF PUBLICATION. REPORT IS FOR AN UNKNOWN NUMBER OF PRODISC-C IMPLANTS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PRODUCT DEVELOPMENT EVALUATION WAS UPDATED: NO PRODUCT WAS RETURNED FOR EVALUATION. A SEARCH ON PUB-MED OF ¿PRODISC-C AND OSSIFICATION¿ RESULTED IN FINDING TEN ARTICLES. A REVIEW OF THE RELEVANT LITERATURE INDICATES THAT THE INCIDENCE OF HETEROTOPIC OSSIFICATION (HO) RANGES ANYWHERE FROM 20-71% OF PRODISC-C PATIENTS. IN MORE SEVERE CASES, AUTOFUSION (0-18.8%) CAN OCCUR, PREVENTING SEGMENTAL MOTION THE IMPLANT WAS DESIGNED TO ALLOW. DESPITE THIS POTENTIAL LIMITATION, PATIENTS WITH HO CONTINUE TO DO WELL CLINICALLY, AND NO SPECIFIC HARMS TO THE PATIENT WERE IDENTIFIED. ALTHOUGH SEVERAL FACTORS HAVE BEEN CITED AS POTENTIAL INITIATORS OF HO, THE DEFINITIVE CAUSE(S) REMAINS UNKNOWN. THE PRODISC-C PRODUCT LABEL SPECIFICALLY LISTS AS A POTENTIAL RISK ASSOCIATED WITH IMPLANTS IN THE SPINE ¿BONE FORMATION THAT MAY REDUCE SPINAL MOTION OR RESULT IN A FUSION, EITHER AT THE TREATED LEVEL OR AT ADJACENT LEVELS.¿ THE JOURNAL ARTICLE IN QUESTION FOLLOWS PATIENTS WITH HO 5 YEARS POST OPERATIVELY, GRADES THE HO ON AN ESTABLISHED SCALE AND MEASURES RANGE OF MOTION. IT SHOWS THAT THE MEAN DIFFERENCES IN HEIGHT AND ROM ARE HIGHER IN PATIENTS WITH A HIGHER GRADE HO WHEN COMPARED TO THE LOWER HO GROUP. THE STUDY FAILS TO SHOW ANY NEGATIVE CLINICAL OUTCOMES BASED ON THE FORMATION OF OSTEOPHYTES OR THE DECREASED RANGE OF MOTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS LITERATURE REVIEW PERFORMED BY PRODUCT DEVELOPMENT NOTED THE FOLLOWING: A REVIEW OF THE RELEVANT LITERATURE INDICATES THAT THE INCIDENCE OF HETEROTOPIC OSSIFICATION (HO) RANGES ANYWHERE FROM 20-71% OF PRODISC-C PATIENTS. IN MORE SEVERE CASES, AUTOFUSION (0-18.8%) CAN OCCUR, PREVENTING SEGMENTAL MOTION THE IMPLANT WAS DESIGNED TO ALLOW. DESPITE THIS POTENTIAL LIMITATION, PATIENTS WITH HO CONTINUE TO DO WELL CLINICALLY, AND NO SPECIFIC HARMS TO THE PATIENT WERE IDENTIFIED. ALTHOUGH SEVERAL FACTORS HAVE BEEN CITED AS POTENTIAL INITIATORS OF HO, THE DEFINITIVE CAUSE(S) REMAINS UNKNOWN. THE PRODISC-C TECHNIQUE GUIDE SPECIFICALLY OUTLINES CERTAIN TECHNIQUES IN PERFORMING THE DISCECTOMY, DECOMPRESSION, AND REMOBILIZATION OF THE DISC SPACE (PRIOR TO IMPLANTATION) TO HELP MINIMIZE THE POTENTIAL FOR HO. IT STATES: PRESERVE THE INTEGRITY OF THE BONY ENDPLATES; ONLY THE CARTILAGINOUS ENDPLATES SHOULD BE EXCISED. ENDPLATE REMODELING SHOULD ONLY BE PERFORMED IF POSTERIOR OSTEOPHYTES INTERFERE WITH IMPLANT POSITIONING OR EXCISION IS NECESSARY FOR NEURAL DECOMPRESSION. THE UNCINATUS PROCESS SHOULD BE PRESERVED. USE MANUAL INSTRUMENTS WHEN BONY REMODELING IS NECESSARY. MORE HIGHLY COLLAPSED CERVICAL DISC SPACES MAY REQUIRE AGGRESSIVE ENDPLATE REMODELING AND DISTRACTION FOR REMOBILIZATION, WHICH COULD CREATE A HIGHLY OSTEOGENIC ENVIRONMENT. DISC SPACES THAT ARE NOT REMOBILIZED ADEQUATELY MAY HAVE LIMITED MOTION, WHICH MAY ENCOURAGE BONE FORMATION AND POSSIBLE FUSION. JUST PRIOR TO CLOSING OF THE SURGICAL WOUND, THE TECHNIQUE GUIDE RECOMMENDS: COPIOUS SALINE LAVAGE IS RECOMMENDED TO REMOVE OSTEOGENIC STIMULI (BLOOD/BONE MARROW). THE PRODISC-C PRODUCT LABEL SPECIFICALLY LISTS AS A POTENTIAL RISK ASSOCIATED WITH IMPLANTS IN THE SPINE - BONE FORMATION THAT MAY REDUCE SPINAL MOTION OR RESULT IN A FUSION, EITHER AT THE TREATED LEVEL OR AT ADJACENT LEVELS.

    Description of Event or Problem · 1

    ABSTRACT RECEIVED: CERVICAL DISC ARTHROPLASTY WITH PRODISC-C ARTIFICIAL DISC: 5-YEAR RADIOGRAPHIC FOLLOW-UP RESULTS; ZHAO YB, SUN Y, ZHOU FF, LIU ZJ; CHINESE MEDICAL JOURNAL (OCT.2013), 126(20):3809-11. THROUGH RADIOGRAPHIC EVALUATION, THE STUDY INVESTIGATED OUTCOMES OF CERVICAL ARTHROPLASTY USING PRODISC-C PROSTHESIS. STATIC AND DYNAMIC FLEXION-EXTENSION LATERAL RADIOGRAPHIC IMAGES WERE TAKEN AT BASELINE AND AT FOLLOW-UP. OF TWENTY SIX PATIENTS WHO HAD SINGLE-LEVEL PRODISC-C ARTHROPLASTY WERE FOLLOWED UP FOR A MEAN PERIOD OF 63 MONTHS. THE RANGE OF MOTION AT THE OPERATED LEVEL WAS 9.3+/-3.7 AT BASELINE AND 7.3+/-3.5 AT FINAL FOLLOW-UP, WITH A SIGNIFICANT DIFFERENCE (P < 0.05). SEVENTEEN OF 26 LEVELS (65.4%) DEVELOPED HETEROTOPIC OSSIFICATION: THREE WERE CLASSIFIED AS GRADE II, 13 WERE CLASSIFIED AS GRADE III, AND 1 AS GRADE IV, ACCORDING TO (B)(4) CLASSIFICATION. FORTY NINE ADJACENT SEGMENTS WERE EVALUATED BY LATERAL X-RAY AND 18 (36.7%) SEGMENTS DEVELOPED ADJACENT SEGMENT DEGENERATIONS. THE STUDY CONCLUDED PRODISC-C ARTHROPLASTY HAD ACCEPTABLE RADIOGRAPHIC RESULTS AT 5-YEAR FOLLOW-UP. RANGE OF MOTION WAS PRESERVED. HOWEVER, MORE THAN 60% OF PATIENTS DEVELOPED HETEROTOPIC OSSIFICATION. THIS REPORT IS 1 OF 1 FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660362 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1