BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BKP CEMENT

    MDR report key: 12381299 · Received August 28, 2021

    Report

    Report Number
    1030489-2021-01096
    Event Type
    Malfunction
    Date Received
    August 28, 2021
    Date of Event
    June 26, 2021
    Report Date
    August 28, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: AVERAGE 76.04 YEARS (66-87 YEARS). SEX: 22 MALES AND 50 FEMALES. PRODUCT CODE: NDN. COMMON DEVICE NAME: CEMENT, BONE, VERTEBROPLASTY. COUNTRY: CHINA. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION : WANG C, ET AL. COMPARISON OF PERCUTANEOUS CURVED KYPHOPLASTY AND BILATERAL PERCUTANEOUS KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: A RANDOMIZED CONTROLLED TRIAL. BMC MUSCULOSKELETAL DISORDERS (2021) 22:588. EVENT SUMMARY- PERCUTANEOUS CURVED KYPHOPLASTY PUNCTURE NEEDLE AND BONE CEMENT HIGH-PRESSURE PERFUSION INSTRUMENT WAS PURCHASED FROM NINGBO HUARUN BIOTECHNOLOGY CO. (CHINA), WHILE ACRYLIC RESIN BONE CEMENT WAS PURCHASED FROM STRYKER INSTRUMENTS (FRANCE). PKP WAS PERFORMED WITH A BILATERAL APPROACH USING PKP APPARATUS AND BONE CEMENT FROM KYPHON CORPORATION (USA). THE TOTAL SURGICAL AND INTRAOPERATIVE FLUOROSCOPY TIMES OF THE PCKP GROUP WERE SIGNIFICANTLY LOWER THAN THOSE OF THE TRADITIONAL PKP GROUP (P<(><<)>0.05). THREE CASES OF BONE CEMENT LEAKAGE OCCURRED IN THE PCKP GROUP IN THE PARAVERTEBRAL BODY WITHOUT VASCULAR LEAKAGE. WHEN THE PUNCTURE NEEDLE REACHED THE IDEAL POSITION IN THE VERTEBRAL BODY, BONE CEMENT COULD BE DISTRIBUTED IN THE ANTERIOR AND MIDDLE PART OF THE VERTEBRAL BODY IN PCKP GROUP, WHILE THE BONE CEMENT INJECTED BY TRADITIONAL PKP AFTER BILATERAL BALLOON DILATION WAS MAINLY DISTRIBUTED IN THE SIDES OF THE VERTEBRAL BODY. PERFUSION, LEAKAGE AND DISTRIBUTION OF BONE CEMENT: TRADITIONAL PKP GROUP HAD A HIGHER BONE CEMENT PERFUSION VOLUME, WITH AN AVERAGE PERFUSION VOLUME OF 4.78 ± 0.67 ML, COMPARED WITH THAT OF THE PCKP GROUP (P<(><<)>0.05). THERE WAS ONLY 1 CASE OF SMALL PARAVERTEBRAL SEGMENT INTRAVASCULAR LEAKAGE AND NO DISTANT INTRAVASCULAR LEAKAGE. POSTOPERATIVE COMPLICATIONS: THERE WERE 3 CASES OF LEAKAGE IN THE PCKP GROUP (1 CASE IN THE INTERVERTEBRAL SPACE, 1 CASE IN THE LATERAL POSITION OF THE DISEASED VERTEBRAE, AND 1 CASE IN THE ANTERIOR POSITION OF THE DISEASED VERTEBRAE), AND 8 CASES IN THE PKP GROUP (3 CASES IN THE INTERVERTEBRAL SPACE, 1 CASE IN THE PARAVERTEBRAL SEGMENT INTRAVASCULAR, 2 CASES IN THE LATERAL POSITION OF THE DISEASED VERTEBRAE, AND 2 CASES IN THE ANTERIOR POSITION OF THE DISEASED VERTEBRAE). AMONG THE 72 CASES, THERE WERE NO SERIOUS COMPLICATIONS SUCH AS PULMONARY EMBOLISM, SPINAL CANAL STENOSIS, SPINAL CORD COMPRESSION OR NERVE INJURY 6 MONTHS AFTER THE OPERATION. METHODS: SEVENTY-TWO PATIENTS WITH SINGLE-LEVEL THORACOLUMBAR OVCF WERE RANDOMLY DIVIDED INTO 2 GROUPS (36 PATIENTS IN EACH) AND WERE SUBJECTED TO EITHER PCKP OR BILATERAL PKP. THE INTRAOPERATIVE FLUOROSCOPY TIME, TOTAL SURGICAL TIME, BONE CEMENT INJECTION VOLUME, BONE CEMENT LEAKAGE, PREOPERATIVE AND POSTOPERATIVE ANTERIOR VERTEBRAL HEIGHT, COBB ANGLES, VISUAL ANALOG SCALES (VAS) AND OSWESTRY DISABILITY INDEX QUESTIONNAIRE (ODI) WERE RECORDED. RADIOGRAPHIC RESULTS- THE ANTERIOR HEIGHT OF THE VERTEBRAL BODY IN THE PCKP GROUP AND TRADITIONAL PKP GROUP WERE RESPECTIVELY 21.93 ± 4.05MM AND 20.95 ± 3.34MM BEFORE THE OPERATION AND WERE INCREASED BY 2.79MM (FINAL 24.72 ± 3.47 MM) AND 3.01MM (FINAL 23.96 ± 3.36 MM) RESPECTIVELY AFTER THE OPERATION(P<(><<)>0.05). HOWEVER, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE HEIGHT OF THE ANTERIOR VERTEBRAL BODY BETWEEN THE TWO GROUPS BEFORE AND AFTER SURGERY (P>0.05). COBB¿S ANGLES IN THE PCKP GROUP WERE 16.44° ± 9.06°, WHILE THAT OF THE TRADITIONAL PKP GROUP WAS 18.01° ± 12.00° BEFORE OPERATION. AFTER THE OPERATION, COBB¿S ANGLES DECREASED TO 10.76° ± 10.10° AND 12.35° ± 13.53° FOR PCKP AND PKP GROUPS RESPECTIVELY (P<(><<)>0.05). THERE WAS NO SIGNIFICANT DIFFERENCE IN COBB¿S ANGLE BETWEEN THE TWO GROUPS BEFORE AND AFTER OPERATION (P>0.05). RESULTS: BOTH GROUPS OF PATIENTS HAD A TREND TOWARDS IMPROVEMENTS IN VAS AND ODI SCORES 24 H AND 6 MONTHS AFTER SURGERY, WHEN COMPARED TO PREOPERATIVE RESULTS, DESPITE LACK OF STATISTICAL SIGNIFICANCE. THE TOTAL SURGICAL AND INTRAOPERATIVE FLUOROSCOPY TIMES AND INTRAOPERATIVE BONE CEMENT INJECTION VOLUME WERE SIGNIFICANTLY DECREASED IN THE PCKP GROUP THAN THOSE IN THE PKP GROUP. THE ANTERIOR EDGE HEIGHT AND COBB ANGLE OF THE INJURED VERTEBRA WERE SIMILARLY IMPROVED AFTER OPERATION IN BOTH GROUPS. CONCLUSION: STUDY CONCLUDES PCKP IS SAFER, LESS INVASIVE AND QUICKER THAN TRADITIONAL BILATERAL PKP DESPITE SIMILAR SHORT-TERM EFFECTS FOR THE TREATMENT OF OVCF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278648 BKP CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1