BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 12096740 · Received June 30, 2021

    Report

    Report Number
    1526439-2021-01364
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SUMMIT OCCIPITOCERVICAL PLATE/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LIU J., HE R., WANG C., (2021) SURGICAL TREATMENT OF A COMPLEX CRANIOCERVICAL MALFORMATION COMBINED WITH POSTERIOR CRANIAL FOSSA TERATOMA: A CASE REPORT AND LITERATURE REVIEW, CHINESE NEUROSURGICAL JOURNAL VOLUME 7:9, PAGES 1-6, (CHINA). THIS STUDY PRESENTS A CASE OF A PATIENT WITH COMPLEX CRANIOCERVICAL MALFORMATIONS AND POSTERIOR CRANIAL FOSSA TUMORS WHO UNDERWENT TWO SURGERIES WITH SATISFACTORY RESULTS. A CASE OF A (B)(6) YEAR-OLD FEMALE ADMITTED WITH A COMPLAINT OF NUMBNESS AND WEAKNESS IN THE RIGHT UPPER LIMB FOR 4 MONTHS. NO PREVIOUS MEDICAL HISTORY WAS AVAILABLE. PHYSICAL EXAMINATION SHOWED THAT HER NECK WAS SHORT, WITH LOW POSTERIOR HAIRLINE, CRANIAL NERVE SIGN (-), RIGHT UPPER EXTREMITY WITH MOTOR POWER OF 4/5, ROMBERG¿S SIGN (+), AND BABINSKI¿S SIGN (+). IMAGING EXAMINATION, INCLUDING PLAIN X-RAY, COMPUTERIZED TOMOGRAPHY (CT) SCANNING, AND MAGNETIC RESONANCE IMAGING (MRI), REVEALED SEVERE ATLANTOAXIAL DISLOCATION WITH MULTI-SEGMENTAL VERTEBRAE FUSION OF THE CERVICAL AND THORACIC SPINE. THE COMPRESSION ON THE VENTRAL SIDE OF THE FORAMEN MAGNUM WAS OBVIOUS. ADDITIONALLY, THE MASS IN THE POSTERIOR CRANIAL FOSSA WAS CONSIDERED A CONGENITAL TUMOR. RESECTION OF THE POSTERIOR CRANIAL FOSSA TUMOR AND OCCIPITOCERVICAL FIXATION USING SUMMIT OCCIPITOCERVICAL INTERNAL FIXATION SYSTEM (DEPUY SPINE, RAYNHAM, MA, USA) AND FUSION WERE SIMULTANEOUSLY PERFORMED FROM A SINGLE POSTERIOR APPROACH. DURING THE OPERATION, IT WAS FOUND OUT THAT THE PATIENT HAD OSTEOPOROSIS, AND THUS THE BILATERAL C2 PEDICLE WAS EASY TO SPLIT WHEN THE SCREW WAS IMPLANTED; NO REDUCTION EXISTED BY APPLYING POSTERIOR THUMB PRESSURE, BY ANTERIORLY COMPRESSING THE C2 SPINOUS PROCESS. HAVING LITTLE CHOICE A LATERAL MASS AND LAMINAR SCREW WERE INSERTED. THEN, AN INTRAOPERATIVE X-RAY SHOWED A PARTIAL REDUCTION OF AAD WAS OBTAINED. THE NUMBNESS AND WEAKNESS OF THE LIMBS WERE NOT RELIEVED AFTER THE OPERATION, AND THE PATIENT HAD DIFFICULTY WALKING BECAUSE OF HER UNSTEADY GAIT. HISTOPATHOLOGY OF THE POSTERIOR CRANIAL FOSSA LESION INDICATED OF ¿MATURE TERATOMA¿. TUMOR RESECTION WAS RELATIVELY SATISFACTORY, BUT THE ATLANTOAXIAL DISLOCATION BECAME EVEN WORSE. THE COMPRESSION OF THE BRAINSTEM AND THE UPPER CERVICAL CORD WAS INCREASED CONSISTENT WITH THE CLINICAL MANIFESTATIONS. A REVISION OPERATION WAS PERFORMED 1 MONTH LATER. THE PREVIOUSLY INSERTED INTERNAL FIXATION SYSTEM WAS EXTRACTED FROM THE POSTERIOR APPROACH. NEXT, 3.5-MM-DIAMETER UNIAXIAL C2 PEDICLE SCREWS WERE INSERTED. THE POSITION OF THE C2 PEDICLE SCREWS WAS SUITABLE, BUT THE AAD REDUCTION WAS UNACCEPTABLE AS ASSESSED ON THE LATERAL INTRAOPERATIVE RADIOGRAPH. THEN ANTERIOR TRANSORAL RELEASE WAS PERFORMED. A REDUCTION OF THE ATLANTOAXIAL JOINT WAS PROGRESSIVELY ATTAINED. FINALLY, POSTERIOR OCCIPITOCERVICAL FIXATION FUSION WAS PERFORMED IMMEDIATELY BY A COMBINATION OF C2 PEDICLE SCREWS AND AN OCCIPITOCERVICAL PLATE SYSTEM. AFTER THE SECOND OPERATION, THE PATIENT¿S SYMPTOMS IMPROVED SIGNIFICANTLY. POSTOPERATIVE MRI INDICATED THAT THE COMPRESSION OF THE MEDULLA OBLONGATA AND THE UPPER CERVICAL CORD WAS SIGNIFICANTLY RELIEVED, AND THE CERVICOMEDULLARY ANGLE RETURNED TO NORMAL. HOWEVER, OBVIOUS LOOSENING AND PULL-OUT OF BILATERAL C2 PEDICLE SCREWS AND C3 LATERAL MASS SCREWS WERE FOUND ON THE CT SAGITTAL RECONSTRUCTION IMAGE. HALO-VEST IMMOBILIZATION WAS IMMEDIATELY PERFORMED. LATER, THE PATIENT EXPERIENCED FEVER AND HEADACHE DUE TO AN INTRACRANIAL INFECTION CONFIRMED BY A LUMBAR PUNCTURE. SHE WAS CURED BY CONTINUED LUMBAR CEREBROSPINAL FLUID DRAINAGE AND WAS SAFELY DISCHARGED FROM THE HOSPITAL 10 DAYS POSTOPERATIVELY. FOUR MONTHS AFTER THE OPERATION, CT SHOWED FUSION SIGNS. HALO-VEST FIXATION WAS REMOVED HALF A YEAR AFTER THE OPERATION WHEN THE LATERAL RADIOGRAPH OF THE CERVICAL SPINE SHOWED A BONE BRIDGE HAD BEEN FORMED IN THE OCCIPITOCERVICAL JUNCTION. ONE YEAR AFTER THE OPERATION, X-RAY CONFIRMED THAT A SOLID FUSION WAS ACHIEVED AND THE INTERNAL FIXATION WAS STABLE. 2- YEAR FOLLOW-UP EXAMINATION REVEALED A SUCCESSFUL CLINICAL OUTCOME. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE SUMMIT OCCIPITOCERVICAL PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988359 UNKNOWN PLATES INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention