BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR END PLATE LARGE-STERILE

    MDR report key: 5743355 · Received June 22, 2016

    Report

    Report Number
    2530088-2016-10168
    Event Type
    Injury
    Date Received
    June 22, 2016
    Report Date
    June 3, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT DEVELOPMENT AND MANUFACTURING INVESTIGATIONS WERE PERFORMED FOR THE COMPLAINT DEVICE PRODISC-L COMPONENT (INFERIOR END PLATE LARGE-STERILE, PART NUMBER PDL-L-IP00S, LOT NUMBER 7082746). THE DEVICE WAS RECEIVED BY WITH THE FOLLOWING COMPLAINT DESCRIPTION: IT WAS REPORTED THAT A PATIENT FELT LEG PAIN APPROXIMATELY TWO YEARS AFTER A PRODISC-L IMPLANTATION. IMAGING APPEARED TO SHOW THE MIGRATION OF BOTH THE POLYETHYLENE INLAY AND THE INFERIOR ENDPLATE AND A REVISION PROCEDURE WAS SCHEDULED TO REMOVE THE IMPLANT AND FUSE THE SEGMENT. WHILE ATTEMPTING TO REMOVE THE IMPLANT ONE OF THE PATIENT VESSELS WAS TORN RESULTING IN A TWO HOUR SURGICAL DELAY FOR THE REPAIR. A SECOND PROCEDURE WAS REQUIRED TO ADD POSTERIOR PERCUTANEOUS PEDICLE SCREWS TO THE SEGMENT. THE MANUFACTURING INVESTIGATION CONCLUDED THAT ALL FEATURES RELEVANT TO THE COMPLAINT CONDITION MET SPECIFICATIONS, AND THE COMPLAINT IS UNCONFIRMED. THE FOLLOWING AS RECEIVED CONDITION WAS NOTED: BONY INGROWTH IN PLASMA COATING ON BACK SURFACE OF IMPLANT, POST-MANUFACTURING BURNISHING ON FLOOR OF THE ENDPLATE WHERE INLAY IS NORMALLY LOCATED AND STRIATIONS/GOUGES IN THE COATING ON THE BACK OF IMPLANT (POST-MANUFACTURING RELATED TO EXPLANTATION). DURING THE PRODUCT DEVELOPMENT INVESTIGATION IT WAS ALSO NOTED THAT THE IMPLANT WAS RETURNED WITH DAMAGE THAT IS CONSISTENT WITH REMOVAL OF THE IMPLANT. THE PRODISC-L TOTAL DISC REPLACEMENT IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L3 TO S1. VISUAL EXAMINATION DID NOT REVEAL ANY DESIGN RELATED ISSUES. THE PRODISC-L DESIGN WAS REVIEWED AND IT WAS DETERMINED THAT AN UPDATE IS NOT WARRANTED AT THIS TIME. THE COMPLAINT CONDITION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE EXPULSION OF THE INLAY OR MIGRATION OF THE ENDPLATE COULD NOT BE DETERMINED. NO DESIGN RELATED ISSUES WERE IDENTIFIED. RETRIEVAL ANALYSIS WAS ALSO PERFORMED FOR THE COMPLAINT DEVICE COMPONENTS WHICH INCLUDE THE POLYETHYLENE INLAY AND INFERIOR ENDPLATE. THIS DEVICE ALSO INCLUDES A SUPERIOR ENDPLATE; HOWEVER, NO COMPLAINT WAS ALLEGED AGAINST THE SUPERIOR ENDPLATE (PART NUMBER PDL-L-SP11S). THE ANALYSIS CONCLUDED THAT THERE IS NO EVIDENCE OF DEVICE FAILURE. THERE IS DAMAGE PRESENT ON THE INFERIOR ENDPLATE, WHICH IS CONSISTENT WITH TOOL MARKS AND SURGICAL REMOVAL TECHNIQUE. THERE ARE SIGNS OF IMPINGEMENT ON THE INFERIOR ENDPLATE. SIGNS OF IMPINGEMENT ARE COMMONLY OBSERVED ON IMPLANTED PRODISC-L DEVICES. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT WAS NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. REVIEW OF THE DHR¿S FOR PDL-L-IP00S AND THE RAW MATERIAL (COCRMORI44.45) INDICATE THERE WERE NO MANUFACTURING DISCREPANCIES RELEVANT TO THE COMPLAINT OF ¿RESULTING PATIENT HARM¿. PRODISC INFERIOR ENDPLATE ¿ PDL-L-IP00S ¿ LOT #7082746. THE INSPECTION SHEETS SHOWED ALL PARTS PASSED VISUAL AND DIMENSIONAL REQUIREMENTS. ONE INSPECTION SHEET SHOWED TWO PARTS SCRAPPED FOR VISUAL NON-CONFORMANCE. REVIEW OF OPERATOR INSPECTION SHEET INDICATES THAT THIS WAS THE ONLY LOT PACKAGED OF THE DAY. REVIEW OF INSPECTION SHEET SHOWS THAT THE QC CHECK WAS PERFORMED AND PARTS MET PROCESS REQUIREMENTS. THE DHR RELEASE CHECK LISTS DID NOT SHOW ANY NON-CONFORMITIES. RAW MATERIAL ¿ 41028 ¿ LOT #4991846. THE RECEIPT TRAVELER WAS REVIEWED FOR CORRECT TYPE, SIZE, GRADE, SHAPE, JDE #, LOT #, AND HEAT #, NO DISCREPANCIES WERE FOUND. REVIEW OF THE INSPECTION SHEET SHOWED THAT THE MATERIAL CONFORMED TO ALL DIMENSIONAL, CHEMICAL CONTENT ANALYSIS, RECERTIFICATION SPECIFICATIONS. PACKING LISTS CONTAINED THE CORRECT TYPE, SIZE, AND HEAT NUMBER. REVIEW OF THE VENDOR CERTIFICATION SHOWED THAT THE MATERIAL WAS PROCESSED PER SYNTHES SPECIFICATION. THE DHR REVIEW CHECK LISTS DID NOT SHOW ANY NON-CONFORMITIES. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    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

    IT WAS REPORTED THAT PRODISC-L REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO MIGRATION OF THE POLYETHYLENE INLAY AND INFERIOR ENDPLATE WHICH MAY HAVE BEEN CAUSING THE PATIENT LEG PAIN. THE PATIENT PRESENTED WITH LEG PAIN DURING A CLINICAL VISIT ON AN UNKNOWN DATE. AFTER REVIEWING X-RAYS, THE SURGEON DETERMINED IT LOOKED AS THOUGH THE POLYETHYLENE INLAY HAD ¿POPPED OUT¿ AND THAT THE INFERIOR ENDPLATE HAD MIGRATED POSTERIORLY. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2013. THE SURGEON¿S ORIGINAL PLAN WAS TO REVISE BY EXPLANTING THE PRODISC-L ANTERIORLY AND PUTTING A CAGE IN TO FUSE IT; THEN FLIP AND DO POSTERIOR PERCUTANEOUS PEDICLE SCREWS BILATERALLY. DURING THE REVISION SURGERY, THE PRODISC-L WAS REMOVED ANTERIORLY AFTER TWO HOURS OF TRYING AND WAS REPLACED WITH A COMPETITOR¿S CAGE. WHILE ATTEMPTING TO REMOVE THE RETRACTORS THERE WAS A TEAR OBSERVED IN ONE OF THE PATIENTS VESSELS. THE TEAM OF SURGEONS PROCEEDED TO CORRECT THE TEAR PROLONGING THE PROCEDURE FOR ANOTHER TWO HOURS. DUE TO THE COMPLICATIONS OF THE SURGERY ANOTHER REVISION SURGERY IS SCHEDULED IN ORDER TO PERFORM A POSTERIOR PERCUTANEOUS PEDICLE SCREWS BILATERALLY. THE PATIENT WAS REPORTED AS ¿FINE¿ FOLLOWING THE FIRST REVISION SURGERY. THE REPORTER HAS CONFIRMED THAT THE SECOND PROCEDURE WAS COMPLETED SUCCESSFULLY ON (B)(6) 2016 WITHOUT ANY DELAYS OR ISSUES. IT WAS STATED THAT IT IS UNKNOWN AS TO WHAT CAUSED THE TEAR INDICATED DURING THE PROCEDURE TO REMOVE THE PDL IMPLANT. THE SURGEONS WERE NOT SURE WHAT CAUSED THE TEAR. THE RETRACTOR BLADES USED DURING THE PROCEDURE WERE A COMPETITOR¿S PRODUCT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396459 INFERIOR END PLATE LARGE-STERILE PROTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 7082746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention