BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 2992542 · Received March 7, 2013

    Report

    Report Number
    0009617544-2013-00062
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    September 4, 2009
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY AND RISK ANALYSIS. RESULTS: COMPLAINT HISTORY: 6 COMPLAINTS WERE RECEIVED FOR POSTOPERATIVE FAILURE OF CONSTRUCTION USING THOR IMPLANTS (PLATES AND SCREWS). IN 4 CASES THE FAILURE IS LINKED TO BACK OUT OF A SCREW FROM PLATE. IN TWO CASES A PLATE SCREW WAS FOUND BROKEN. RISK ANALYSIS: FROM EVENT DESCRIPTION IT IS NOT CLEAR WHAT EXACT FAILURE IS OCCURRED. IT IS ONLY REPORTED THAT THE FUSION WAS NOT ACHIEVED AND SOME OF THE SCREWS WERE DAMAGED. IT IS NOT HOWEVER INDICATED WHAT TYPE OF DAMAGE OCCURRED WITH SCREWS. NOT POSSIBLE TO REVIEW THE RISK DOCUMENTATION. THOUGH, THE REPORTED EVENT CAUSED A REVISION SURGERY HENCE THE ASSOCIATED SEVERITY LEVEL IS S3. CONCLUSION: IT IS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION OF L5-S1 WITH SUBSEQUENT SCREWS AND PLATE INSERTION. NO IMPLANTS WERE RETURNED FOR INVESTIGATION. THE X-RAYS ARE NOT AVAILABLE AS WELL AS ANY ADDITIONAL INFORMATION. AMONG STRYKER PRODUCT BRANDS ONLY THOR BRAND HAS PLATES FOR THE CORRECTION IN THORACO-LUMBAR REGION OF SPINE. THE REVIEW OF COMPLAINTS RECEIVED FOR POSTOPERATIVE FAILURE OF CONSTRUCTION WE DID NOT REVEAL ANY TREND. THE MAJORITY OF COMPLAINTS WERE LINKED WITH POSTOPERATIVE BACK OUT OF SCREWS. ONE COMPLAINT WAS RECEIVED FOR BREAKAGE OF PLATE SCREW (THE INVESTIGATION IS IN PROGRESS). THUS, BASED ON AVAILABLE INFORMATION IT IS IMPOSSIBLE TO DETERMINE WHAT EXACT FAILURE OF IMPLANTS TOOK PLACE IN CURRENT CASE. IF ANY INFORMATION IS MADE AVAILABLE, THE INVESTIGATION COULD BE REOPENED AND COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION OF L5-S1 WITH SUBSEQUENT SCREWS AND PLATE INSERTION. ALLEGEDLY, THREE MONTHS LATER X-RAYS REVEALED THAT THE FUSION HAD NOT HELD AND SOME OF THE SCREWS WERE DAMAGED. IT WAS ADDITIONALLY REPORTED THAT THIS LED TO SURGICAL REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION OF L5-S1 WITH SUBSEQUENT SCREWS AND PLATE INSERTION. ALLEGEDLY, THREE MONTHS LATER X-RAYS REVEALED THAT THE FUSION HAD NOT HELD AND SOME OF THE SCREWS WERE DAMAGED. IT WAS ADDITIONALLY REPORTED THAT THIS LED TO SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98124 UNKNOWN_SPINE_PRODUCT PEDICLE SCREW NKB STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R