BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2678346 · Received August 1, 2012

    Report

    Report Number
    2953769-2012-00108
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    May 1, 2011
    Report Date
    July 3, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: YUTAKA KOUNO, HOUGAKU GEN, YOSHIO SAKUMA, RENTARO MUROTANI, YASUYUKI KOJIKA, GO HAYASAKA, KEI MIYAGAWA; 2012. SURGICAL RESULTS OF BALLOON KYPHOPLASTY FOR OSTEOPOROTIC VERTEBRAL FRACTURES. JOURNAL OF SPINE RESEARCH VOL 3 (3). (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NINE (9) PATIENTS THAT UNDERWENT BKP AND WERE ABLE TO BE FOLLOWED MORE THAN 3 MONTHS, WERE INCLUDED IN A STUDY ((B)(6)). THE TREATED LEVELS WERE T8 (N =1), T10 (N =1), T12 (N =3), L1 (N =1), L2 (N =2), L3 (N =2), AND L5 (N =1). THE MEAN PERIOD FROM THE ONSET DATE OF PAIN TO THE OPERATION DATE WAS 2.8 MONTHS (RANGE: 1-7 MONTHS). MINOR POSTERIOR WALL INJURY WITH CONTINUITY WAS OBSERVED IN 5 VERTEBRAE, AND VACUUM CLEFTS WERE FOUND IN 11 VERTEBRAE. THE MEAN OPERATIVE TIME WAS 42 MINUTES (RANGE: 27-54 MIN), AND THERE WERE NO SERIOUS PERIOPERATIVE COMPLICATIONS. IT WAS REPORTED THAT CEMENT LEAKAGE INTO THE VERTEBRAL DISC OCCURRED IN A PATIENT HAVING A SMALL CLEFT ADJACENT TO THE SUPERIOR ENDPLATE. THE COMPLICATION APPEARED WITHIN 1 MONTH AFTER THE SURGERY. THE PATIENT SHOWED NO SYMPTOMS AND NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON SUNNYVALE MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR