BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP PEEK INTERSPINOUS SPACER

    MDR report key: 2921090 · Received January 17, 2013

    Report

    Report Number
    2953769-2013-00008
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    March 12, 2012
    Report Date
    June 9, 2016
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE USING A 10MM INTERSPINOUS SPACER FOR LUMBAR CANAL STENOSIS AT L4/5. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SPINOUS PROCESS FRACTURE AT L5 APPROXIMATELY 11 DAYS POST-OP. PER THE REPORT, "FLUID COLLECTION AND HEMATOMA ALSO HAD OCCURRED AT THE SAME SITE, SO IT TOOK A LONG TIME TO WOUND HEALING." THE PATIENT WAS REPORTEDLY DISCHARGED TWO DAYS LATER AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    "OTHER LUMBAR SPINE SURGERY" WAS REPORTED AS THE PATIENT'S TREATMENT HISTORY FOR THE PAIN. DETAILED INFORMATION ON THE SURGERY HAS BEEN REQUESTED. ALSO, ON (B)(6) 2012, X-RAY AND CT REVEALED ABNORMALITIES IN INTER-SPINOUS PROCESS DISTANCE AT THE TREATED LEVEL AND INAPPROPRIATE X-STOP POSITION (DETAILS UNSPECIFIED). SUBSEQUENT IMAGING EXAMINATIONS PERFORMED ON (B)(6) 2012, AND (B)(6) 2013 SHOWED THE SAME ABNORMAL FINDINGS (I.E., ABNORMALITIES IN INTER-SPINOUS PROCESS DISTANCE AT THE TREATED LEVEL AND INAPPROPRIATE X-STOP POSITION). ACCORDING TO THE PATIENT'S 2-YEAR POSTOPERATIVE CRF, THESE ABNORMAL FINDINGS REMAINED UNCHANGED AS DEMONSTRATED ON CT AND MRI ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION ABOUT THE PAIN ON BACK AND LEG DURING FOLLOW-UP PERIOD IS UPDATED THAT PHYSICIAN CONSIDERS THE PAIN OCCURRED BECAUSE INTERVERTEBRAL DISC SPACE COULD NOT BE KEPT OPEN DUE TO L5 SPINOUS PROCESS FRACTURE AND REMOVAL OF COMPLETION OF DURAL TUBE WAS NOT ENOUGH. THE PHYSICIAN COMMENTED THAT THE PHYSICIAN PRESCRIBED ANTIDEPRESSANT DRUG (DETAILS UNSPECIFIED) AND ANTICONVULSANT DRUG (DETAILS UNSPECIFIED) DUE TO THE PATIENT DID NOT MAKE A GOOD RECOVERY FROM X-STOP SURGERY AND WAS NOT CAUSALITY RELATED TO X-STOP PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26976 X-STOP PEEK INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MDT KYPHON SUNNYVALE MFG NA 2237901

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization