BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE 5MM-STERILE

    MDR report key: 6149054 · Received December 6, 2016

    Report

    Report Number
    2530088-2016-10336
    Event Type
    Injury
    Date Received
    December 6, 2016
    Report Date
    November 12, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE SUPERIOR AND INFERIOR ENDPLATE WITH INLAY ATTACHED WERE RECEIVED WITH POSTPRODUCTION IATROGENIC DAMAGE USED FOR REMOVAL OF DEVICES FROM PATIENT. THE SUPERIOR END PLATE HAS POSTPRODUCTION VISIBLE DAMAGE CAUSED BY BURR FOR REMOVAL OF DEVICE FROM PATIENT AS STATED BY SURGEON. THE DAMAGE INCLUDES NICKS AND SCRATCHES VISIBLE PRIMARILY ON THE RAISED EDGE ADJACENT TO THE POLISHED SPHERICAL SURFACE IN THE ANTERIOR DIRECTION OF THE PLATE. BURR DAMAGE IS ALSO VISIBLE ON THE NONFUNCTIONAL SURFACES ON TOP, BOTTOM AND KEEL OF PLATE. THE INFERIOR END PLATE WITH INLAY STILL ATTACHED HAS POSTPRODUCTION VISIBLE DAMAGE CAUSED BY BURR FOR REMOVAL OF DEVICE FROM PATIENT AS STATED BY SURGEON. DAMAGE TO THE INFERIOR END PLATE INCLUDES NICKS AND SCRATCHES ON FACES ADJACENT TO THE INLAY IN THE ANTERIOR DIRECTION OF THE PLATE. BURR DAMAGE IS ALSO VISIBLE ON THE NONFUNCTIONAL SURFACES ON TOP, BOTTOM AND KEEL OF PLATE. THE INLAY HAS POSTPRODUCTION VISIBLE DAMAGE CAUSED BY BURR FOR REMOVAL OF DEVICE FROM PATIENT AS STATED BY SURGEON. THE DAMAGE INCLUDES NICKS, SCRATCHES AND UNDERCUT VISIBLE PRIMARILY IN THE ANTERIOR DIRECTION OF THE INLAY. BURR DAMAGE HAS UNDERCUT APPROXIMATELY 75% OF THE SPHERICAL SURFACE AND HAS ERODED APPROXIMATELY 25% OF SAME SPHERICAL SURFACE. ALL DESCRIBED NONCONFORMITIES ARE POSTPRODUCTION IATROGENIC DAMAGE AS SEEM FROM A MANUFACTURING PERSPECTIVE. THE COMPLAINT CONDITION IS NOT RELATED TO A MANUFACTURING CAUSE. 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)(4). PART 09.820.045S, LOT 5831974: LOT MANUFACTURED AT (B)(4) PLANT ON AUGUST 13, 2008. PART 09.820.045S IS AN ASSEMBLY MADE OF PART 09.820.045.1 (INFERIOR PLATE SIZE L) LOT 5703661, 09.820.045.2 ¿ (SUPERIOR PLATE SIZE L) LOT 5718328 & 09.820.045.3 (INLAY LARGE 5 MM) LOT 5757614. THE DEVICE HISTORY RECORDS (DHR) FOR ALL ASSEMBLY COMPONENTS WERE REVIEWED. THE DEVICE HISTORY RECORDS (DHR) DID NOT CONTAIN ANY NON-CONFORMANCE REPORTS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 FOR THE REMOVAL OF A 5MM PRODISC-C IMPLANT, AT AN UNKNOWN LEVEL, DUE TO COMPLAINTS OF PAIN. THE INITIAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT AN X-RAY REVEALED TOO MUCH MOVEMENT OF THE DEVICE. WHEN REMOVING THE DEVICE, THE SURGEON FELT THAT THE DEVICE LOOKED FINE BUT HAD TO BURR A LITTLE BIT OF THE PLASTIC PART OF THE IMPLANT TO SOFTEN IT TO ALLOW IT TO SLIDE OUT. OTHERWISE, THE IMPLANT WAS EASILY REMOVED WITH THE REMOVAL INSTRUMENTATION. THE PRODISC-C WAS REPLACED WITH A FUSION. IT WAS REPORTED THAT THE SURGEON FELT THE IMPLANT SHOULD HAVE BEEN SIZE 6MM WHICH MIGHT HAVE PREVENTED THE MOVEMENT AND NEED FOR REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND THE PATIENT WAS REPORTED AS STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800249 PRODISC-C IMPLANT LARGE 5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 5831974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention