BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE 5MM-STERILE

    MDR report key: 4222732 · Received November 4, 2014

    Report

    Report Number
    2530088-2014-10345
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: OVER TWO YEARS PRIOR TO EXPLANT ON (B)(6), 2014. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (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.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED: THE FOLLOWING DOCUMENTS WERE REVIEWED: DEVICE HISTORY CHECK LIST, PACKING PROCESS SHEET, AND PACKING LABEL LOG. REVIEW OF THE PACKING PROCESS SHEET SHOWS THAT THE SEALING SETTINGS WERE WITHIN SPECIFICATION, QUALITY CHECK WAS PERFORMED AND PARTS MET SPECIFICATION. THE PACKAGING LABEL LOG SHOWS THAT THE REQUIRED LABEL WERE PRESENT AND MET SPECIFICATION. THE DEVICE HISTORY RECORD RELEASE CHECK LISTS DO NOT SHO ANY NON-CONFORMITY. A SCREENING NOTICE WAS GENERATED ON APRIL 27, 2011 WHICH PASSED REVIEW. ADDITIONAL SCREENING NOTICES WERE GENERATED ON APRIL 10, 2012 FOR ONE PART, APRIL 24, 2012 FOR ONE PART AND JUNE 25, 2012 FOR ONE PART EXCEEDING SHELF LIFE. THESE DEVICES WERE SCRAPPED AND REMOVED FROM THE SYSTEM. THE SCREENING NOTICES ARE NOT RELEVANT TO THE COMPLAINT BECAUSE THEY DO NOT AFFECT THE FUNCTION OF THE DEVICE. REVIEW OF LOT 6417404 SHOWS THAT THE PARTS WERE PROCESSED WITHIN SPECIFICATION. (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.

    Additional Manufacturer Narrative · 1

    (B)(6). A MANUFACTURING EVALUATION WAS COMPLETED: THE INLAY COMPONENT, WHICH IS NORMALLY ASSEMBLED INTO THE INFERIOR PLATE COMPONENT, HAS BEEN REMOVED FROM ITS NORMALLY ASSEMBLED CONDITION INDICATING POST MANUFACTURING DAMAGE OR USE. THE SUPERIOR PLATE COMPONENT EXHIBITS VISIBLE MARRING ON THE PLASMA COATED AND UNCOATED SIDES, AS WELL AS, DISCOLORATION OF THE SURFACES ON THE UNCOATED SIDE OF THE PLATE INDICATING POST MANUFACTURING DAMAGE OR USE. THE FRONT EDGE OF THE SUPERIOR ENDPLATE COMPONENT ALSO EXHIBITS MARRING THAT IS INDICATIVE OF POST MANUFACTURING DAMAGE OR USE. THE INFERIOR PLATE COMPONENT ALSO EXHIBITS VISIBLE SCRATCHES AND MARRING ON BOTH THE PLASMA COATED AND UNCOATED SIDES, AS WELL AS, ON THE INLY MATING SURFACE INDICATIVE OF POST MANUFACTURING DAMAGE OR USE. THE MIDLINE KEEL OF THE INFERIOR PLATE COMPONENT ALSO EXHIBITS DEFORMATION THAT IS INDICATIVE OF POST MANUFACTURING DAMAGE OR USE. THE PRODISC INLY COMPONENT EXHIBITS DISASSEMBLY FROM THE INFERIOR PLATE COMPONENT AND SIGNIFICANT DAMAGE ON ALL SURFACES AND FEATURES OF THE PRODUCT INDICATING POST MANUFACTURING DISASSEMBLY, DAMAGE AND USE. DAMAGE INCLUDES SCRATCHES, DEFORMATION, COMPRESSION, BENDING AND TEARING OF THE BASE OF THE INLAY AND GOUGES AND TEARS VISIBLE ON THE ROUNDED SURFACE OF THE INLAY COMPONENT. A PORTION OF THE INLAY COMPONENT ALSO APPEARS TO BE SEPARATED AND WAS NOT INCLUDED WITH THE RETURNED PRODUCT. THE RELEVANT DRAWINGS AND RISK MANAGEMENT DOCUMENTS WERE REVIEWED. THE DIMENSIONAL FEATURES CANNOT BE VERIFIED ON THE RETURNED PRODUCT FOR CONFORMANCE TO ESTABLISHED REQUIREMENTS BECAUSE ALL OF THE FEATURES WERE SIGNIFICANTLY DAMAGED AND DEFORMED DURING USE OR EXPLANTATION TO REMOVE THE IMPLANT FROM THE PATIENT; AS WELL AS, DUE TO PLASMA COATING OF THE PRODUCT DURING ITS MANUFACTURE. ANY MEASUREMENTS OF THE IDENTIFIED FEATURES RECEIVED FROM THE FIELD WOULD NOT PROVIDE ACCURATE INFORMATION REGARDING WHETHER OR NOT THE FEATURE WAS WITHIN SPECIFICATION AT THE TIME OF MANUFACTURING; POST PLASMA COATED SURFACES WILL PREVENT ACCURATE LOCATION OF THE CMM PROBE TO MEASURE THE FEATURES AND THE COATING COULD ALSO POTENTIALLY DAMAGE THE CMM PROBE TIPS. THE MATERIAL ALSO CANNOT BE VERIFIED WITHOUT DESTRUCTIVE TESTING. HOWEVER, THE LOT RECERTIFICATION DOCUMENT IN THE DEVICE HISTORY RECORD FOR THE REPORTED PRODUCT LOT WAS VERIFIED AS INDICATING THAT THE RAW MATERIAL USED. THE COMPLAINT CONDITION REPORTED AS IMPLANT FAILURE POSTOPERATIVELY : LOOSENED COULD NOT BE CONFIRMED DUE TO INABILITY TO VERIFY CONFORMANCE OF THE RETURNED PRODUCT TO ESTABLISHED SPECIFICATIONS DUE TO SPECIFIED COATING OF RELEVANT DIMENSIONS DURING MANUFACTURE AND/OR POST MANUFACTURING DAMAGE DURING USE AS INTENDED OR EXPLANTATION. 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.

    Additional Manufacturer Narrative · 1

    A RETRIEVAL ANALYSIS OF THE SUBJECT DEVICE (PRODISC-C 09.820.045S) WAS PERFORMED. ALL RETRIEVED DEVICE COMPONENTS (SUPERIOR ENDPLATE, POLYETHYLENE (PE) INLAY, AND INFERIOR ENDPLATE) WERE EXAMINED MACROSCOPICALLY FOR SIGNS OF WEAR AND DAMAGE. THERE IS NO EVIDENCE OF DEVICE FAILURE OR MALFUNCTION. THE IMPLANT COMPONENTS SHOW SIGNS OF NORMAL WEAR COMMONLY OBSERVED IN METAL-ON-PE ARTICULATIONS IN TOTAL JOINT REPLACEMENTS. THERE IS DAMAGE PRESENT ON THE INFERIOR ENDPLATE AND THE POLYETHYLENE INLAY, ALL CONSISTENT WITH TOOL MARKS AND SURGICAL REMOVAL TECHNIQUE. THERE ARE SIGNS OF IMPINGEMENT ON THE SUPERIOR ENDPLATE, INFERIOR ENDPLATE, AND POLYETHYLENE INLAY. THE RISKS OF IMPINGEMENT ARE COVERED IN THE PRODISC-C DESIGN. A PRODUCT DEVELOPMENT INVESTIGATION WAS ALSO PERFORMED FOR THE SUBJECT DEVICE. PRODISC-C IS A SPINAL IMPLANT INTENDED AS A REPLACEMENT FOR DISEASED/ DEGENERATED INTERVERTEBRAL DISCS OF THE CERVICAL SPINE. THE PRODISC-C TOTAL DISC REPLACEMENT PROCEDURE INVOLVES THE REMOVAL OF A DISEASED/ DEGENERATED DISC, AND SUBSEQUENT RESTORATION OF INTERVERTEBRAL DISC HEIGHT AND POTENTIAL FOR MOTION VIA PLACEMENT OF THE IMPLANT. THE PRODDISC-C DESIGN AND PACKAGE INSERTS WERE REVIEWED AND IT WAS DETERMINED THAT AN UPDATE IS NOT WARRANTED AT THIS TIME. THE LOOSENING WAS LIKELY DUE TO EXCESSIVE FORCE APPLIED TO THE IMPLANT BY THE PATIENT. MECHANICAL HAS SHOWN THAT THE DESIGN OF THE DEVICE IS CAPABLE OF WITHSTANDING MAXIMUM SHEAR FORCES ANTICIPATED IN THE CERVICAL SPINE UNDER NORMAL CONDITIONS. THE DESIGN IS ADEQUATE FOR THE INTENDED USE OF THE DEVICE. 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

    IT WAS REPORTED ONE PRODISC-C DEVICE AT C4-C5 WAS EXPLANTED ON (B)(6), 2014, DUE TO DEVICE LOOSENING AND PATIENT'S NECK PAIN. THE SURGEON STATED THE INITIAL IMPLANT SURGERY OCCURRED OVER TWO YEARS AGO AND WENT PERFECTLY. THE PATIENT COMPLAINED OF NECK PAIN AND THE SURGEON BELIEVED THE IMPLANT MIGHT BE LOOSE. THE SURGEON EXPLANTED THE PRODISC-C AND REVISED THE PATIENT TO A SPACER AND PLATE. REPORTEDLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708318 PRODISC-C IMPLANT LARGE 5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 6417404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention