BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 5636724 · Received May 6, 2016

    Report

    Report Number
    2520274-2016-12560
    Event Type
    Injury
    Date Received
    May 6, 2016
    Report Date
    April 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: BULLENS, P., DE WAAL MALEFIJT, M., AND WILLEM LOUWERENS, J. (2010). CONVERSION OF FAILED ANKLE ARTHROPLASTY TO AN ARTHRODESIS TECHNIQUE USING AN ARTHRODESIS NAIL AND A CAGE FILLED WITH MORSELLIZED BONE GRAFT. FOOT AND ANKLE SURGERY, VOLUME 16, PAGES 101-104. THIS REPORT IS FOR AN UNKNOWN SYNMESH WITH UNKNOWN PART AND LOT NUMBERS. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BULLENS, P., DE WAAL MALEFIJT, M., AND WILLEM LOUWERENS, J. (2010). CONVERSION OF FAILED ANKLE ARTHROPLASTY TO AN ARTHRODESIS TECHNIQUE USING AN ARTHRODESIS NAIL AND A CAGE FILLED WITH MORSELLIZED BONE GRAFT. FOOT AND ANKLE SURGERY, VOLUME 16, PAGES 101-104. [NETHERLANDS] HIS WAS RETROSPECTIVE REVIEW OF TWO PATIENTS WITH FAILED ANKLE ARTHROPLASTY PERFORMED ON UNKNOWN DATES. THE STUDY INCLUDED TWO PATIENTS, CASE 1 AND CASE 2. PATIENTS WERE INITIALLY TREATED WITH A NON-SYNTHES DEVICE AND LATER REVISED TO A SYNTHES DEVICE (SYNMESH), ALLOGRAFT, AND A NON-SYNTHES ARTHRODESIS NAIL. THE FOLLOWING COMPLICATIONS OCCURRED AFTER SYNMESH WAS IMPLANTED: CASE #1: (B)(6) YEAR OLD MALE WAS REVISED TO SYNMESH FOLLOWING FAILURE OF SURGERY FOR A NON-SYNTHES DEVICE. POSTOPERATIVELY, A PLASTER CAST WAS APPLIED AND WAS NON WEIGHT BEARING STATUS FOR THE FIRST 4 WEEKS. THEN A WALKING CAST WAS APPLIED AND PATIENT WAS PARTIAL WEIGHT BEARING STATUS ON THE HEEL FOR ANOTHER 4 WEEKS. THEN THE PATIENT WAS FULL WEIGHT BEARING FOR 4 WEEKS WITH THE WALKING CAST. UPON REMOVAL OF THE WALKING CAST, THE ANKLE WAS SLIGHTLY PAINFUL AND A CAST WAS APPLIED FOR ANOTHER 4 WEEKS. THE ANKLE REMAINED PAINFUL; CT SCAN REVEALED NON-UNION (AND GRAFT ISSUES). PATIENT HAD ANOTHER PROCEDURE WHICH INCLUDED DYNAMIZATION OF NON-SYNTHES DEVICES AND LATER, A SOLID UNION WAS ACHIEVED. PATIENT EXPERIENCES A CONTINUOUS (POTENTIALLY NEUROPATHIC) PAIN IN HIND FOOT. RADIOLOGY IMAGING INCLUDED IN ARTICLE. THIS IS REPORT #1 OF #2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNMESH WITH AN UNKNOWN PART NUMBER, LOT NUMBER AND QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291751 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention