BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAMIC COMPRESSION SMA STAPLE SYSTEM

    MDR report key: 2033363 · Received March 30, 2011

    Report

    Report Number
    1030489-2011-00356
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    PMA / PMN Number
    K012081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STAPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. X-RAY REVIEW SHOWS NITINOL STAPLES AT T7, T8, T9, T10, T11 ON THE RIGHT SIDE AND AT L1, L2, L3 ON THE LEFT SIDE. T11 STAPLE APPEARS TO HAVE BEEN REVISED IN ONE IMAGE. NO CLEAR SEPERATION OR MIGRATION OF THE STAPLES IS DELINEATED.

    Additional Manufacturer Narrative · 1

    CRITICAL DIMENSIONAL ANALYSIS WAS CONDUCTED ON SUBJECT STAPLE. THE MEASURED RANGE FOR THE GAP OPENING WAS 13.59MM TO 13.74MM. PRINT SPECIFICATIONS CALL FOR A NOMINAL DIMENSION OF 6MM. THE WIDTH OF THE STAPLE MEASURED 18.7MM VERSUS THE PRINT REFERENCE OF (16.7MM). ALL OTHER OBSERVED DIMENSIONS MEASURED WITHIN THE EXPECTED PRINT SPECIFICATIONS. THERMAL CYCLING OF THE SUBJECT STAPLE WAS NOT ATTEMPTED IN ORDER TO MAINTAIN THE INTEGRITY OF THE SUBJECT STAPLE AS IT EXISTED ON (B)(4), 2011, PER COMPANY INSTRUCTIONS. THE RISK EXISTED THAT IF THE SUBJECT STAPLE WAS COOLED AND FURTHER MANIPULATED THAT IT WOULD NOT BE POSSIBLE TO DISTINGUISH THE OVERSTRESS CONDITION THAT OCCURRED DURING THE SURGICAL PROCEDURE FROM THE TESTING EVALUATION. BASED ON THE EVIDENCE AND LOCATION OF INSTRUMENT MARKS, ALONG WITH THE DIMENSIONAL ANALYSIS, IT IS OUR CONCLUSION THAT THE SUBJECT STAPLE WAS OVER STRAINED IN CONJUNCTION WITH THE SURGICAL PROCEDURE, CREATING A PERMANENT PLASTIC DEFORMATION. THIS INDUCED PLASTIC DEFORMATION CANNOT BE RECOVERED, THE STAPLE WAS PERMANENTLY DAMAGED AND WOULD NOT DEPLOY AS INTENDED ONCE INSERTED. SURFACE DAMAGE AND STRUCTURE DAMAGE AT THE TIP WERE INCURRED DURING THE SURGICAL PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE TO TREAT SCOLIOSIS. IT WAS REPORTED THAT THE IMPLANT DID NOT DEPLOY AFTER PLACEMENT IN THE PATIENT. NINE DAYS POST-OP THE PATIENT REPORTED BACK WITH PAIN AND IMAGING STUDIES WERE PERFORMED. IT WAS OBSERVED THAT THE STAPLE HAD BACKED OUT AND WAS IN THE DIAPHRAGM. THE PATIENT UNDERWENT REVISION SURGERY; THE STAPLE WAS REMOVED AND REPLACED WITH A NEW STAPLE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAMIC COMPRESSION SMA STAPLE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC NA UN10J001

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention