BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4150153 · Received October 7, 2014

    Report

    Report Number
    2520274-2014-13940
    Event Type
    Injury
    Date Received
    October 7, 2014
    Report Date
    September 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: (B)(6) 2012. THIS REPORT IS FOR UNKNOWN PLATE, UNKNOWN QUANTITY, UNKNOWN PART/LOT. KARANDIKAR ET AL (2012, JUNE). COMPLEX PEDIATRIC CERVICAL SPINE SURGERY USING SMALLER NONSPINAL SCREWS AND PLATES AND INTRAOPERATIVE COMPUTED TOMOGRAPHY. JOURNAL OF NEUROSURG: PEDIATRICS, VOL 9, 594-601. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE; KARANDIKAR ET AL (2012, JUNE). COMPLEX PEDIATRIC CERVICAL SPINE SURGERY USING SMALLER NONSPINAL SCREWS AND PLATES AND INTRAOPERATIVE COMPUTED TOMOGRAPHY. JOURNAL OF NEUROSURG: PEDIATRICS, VOL 9, 594-601. IN THIS PAPER THE AUTHOR'S REPORT THEIR SURGICAL EXPERIENCE IN THE TREATMENT OF 31 CHILDREN AGES WITH CRANIOCERVICAL SPINE INSTABILITY USING INTRAOPERATIVE COMPUTED TOMOGRAPHY (CT) AND SMALLER NONTRADITIONAL TITANIUM SCREWS AND PLATES. ALL CHILDREN UNDERWENT PREOPERATIVE SPINE RADIOGRAPHY. THE PREOPERATIVE CT SCANS WERE USED TO DETERMINE THE OPTIMAL SCREW SIZE THAT WOULD FIT THE SPECIFIC SPINAL BONE ANATOMY. NONTRADITIONAL SPINAL HARDWARE INCLUDED SMALLER C1¿2 TRANSARTICULAR SCREW SIZES (2.4 AND 2.7 MM) FROM THE SYNTHES ORTHOPEDIC HAND/FOOT SET AND MANDIBULAR PLATES. TRADITIONAL SPINAL HARDWARE INCLUDED THE 3.5- AND 4.0-MM C1¿2 TRANSARTICULAR SCREWS FROM THE SYNTHES SPINE SET. INTRAOPERATIVE DOPPLER ULTRASONOGRAPHY WAS USED TO VERIFY TRIPHASIC FLOW THROUGH BOTH VERTEBRAL ARTERIES PRIOR TO AND AFTER PLACEMENT OF ALL C1¿2 TRANSARTICULAR SCREWS. ALL PROCEDURES WERE PERFORMED USING INTRAOPERATIVE FLUOROSCOPIC IMAGING AND ELECTROPHYSIOLOGICAL MONITORING THAT INCLUDED SOMATO-SENSORY EVOKED POTENTIALS (SSEPS) AND MOTOR EVOKED POTENTIALS (MEP). ONE OF 2 INTRA-OPERATIVE CT SCANNERS WAS USED TO CONFIRM ADEQUATE POSITIONING OF THE SCREW AND SPINAL HARDWARE AS WELL AS SPINAL ALIGNMENT. POSTOPERATIVE BRACING CONSISTED OF A HALO BRACE, A MINERVA BRACE, OR A MIAMI J BRACE. THIRTY-ONE CHILDREN WHO WERE 17 YEARS OF AGE OR YOUNGER WITH OCCIPITOCERVICAL SPINE INSTABILITY OR SUBAXIAL INSTABILITY UNDERWENT 33 OPERATIVE PROCEDURES. THERE WERE 14 GIRLS AND 17 BOYS. ALL PATIENTS WERE FOLLOWED-UP FOR 3 MONTHS OR MORE. TWENTY-NINE OF 31 CHILDREN HAD ATTAINED SUCCESSFUL FUSION AT THEIR 3-MONTH FOLLOW-UP VISIT, BASED ON CT AND DYNAMIC RADIOGRAPHIC IMAGING. OF THE 47 C1¿2 TRANSARTICULAR SCREWS THAT WERE PLACED, 28 OF 47 WERE NONTRADITIONAL SCREW SIZES. EIGHTEEN OF THE 47 C1¿2 TRANSARTICULAR SCREWS WERE JUDGED TO BE SUBOPTIMALLY PLACED. HALO PIN SITE INFECTIONS WERE THE MOST COMMON COMPLICATION. IN 1 PATIENT (CASE 13), WE LOST BILATERAL ARM AND LEG SSEPS AND MEPS AND POSTOPERATIVELY THE PATIENT WAS WORSE NEUROLOGICALLY. HOWEVER, AT THE 6-MONTH FOLLOW-UP THE PATIENT REGAINED STRENGTH AND WAS BETTER NEUROLOGICALLY COMPARED WITH BEFORE THE OPERATION. THIS IS REPORT # 5 OF 11 FOR (B)(4). THIS REPORT IS FOR UNKNOWN PLATE, UNKNOWN PART/LOT IMPLANTED IN PATIENT# 13. THIS REPORT IS FOR UNKNOWN QUANTITY OF DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627321 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention