BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 12085762 · Received June 29, 2021

    Report

    Report Number
    1526439-2021-01336
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    April 25, 2020
    Report Date
    June 7, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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: HASSLER K., ET AL (2020) ATLANTO-OCCIPITAL TRANSARTICULAR SCREW FIXATION FOR THE TREATMENT OF TRAUMATIC OCCIPITOCERVICAL INSTABILITY IN THE PEDIATRIC POPULATION, WORLD NEUROSURG. VOLUME 140, PAGES :E81-E86. (USA) HTTPS://DOI.ORG/10.1016/J.WNEU.2020.04.129. THIS RETROSPECTIVE STUDY AIMS TO REPORT ON A SMALL CASE SERIES OF PEDIATRIC PATIENTS THAT SUFFERED FROM TRAUMATIC CVJ INSTABILITY WHERE ATLANTO-OCCIPITAL TRANSARTICULAR SCREW FIXATION (AOTSF) WAS ATTEMPTED. FROM 2007 TO 2018, 7 PEDIATRIC PATIENTS (LESS THAN 18 YEARS OF AGE) WITH TRAUMATIC CVJ INSTABILITY WHO UNDERWENT SURGERY FOR OCCIPITOCERVICAL FUSION WERE REVIEWED. OF THESE, A TOTAL OF 3 PATIENTS (9, 11, 17 YEARS OF AGE; MEAN AGE, 12.3 YEARS) UNDERWENT A STANDARD PLATE/ROD/SCREW FIXATION. A TOTAL OF 4 PATIENTS (2 BOYS AND 2 GIRLS; AGES (B)(6) YEARS; MEAN AGE, 4 YEARS) WITH TRAUMATIC CVJ INSTABILITY WHO UNDERWENT WHERE ATLANTO-OCCIPITAL TRANSARTICULAR SCREW FIXATION WERE IDENTIFIED. FURTHERMORE, WE IDENTIFIED ALL PATIENTS THAT HAD AN ATTEMPTED AOTSF AT VALLEYWISE HEALTH MEDICAL CENTER, PHOENIX, ARIZONA. AOTSF WAS DONE USING A NONCANNULATED FULLY THREADED OR PARTIALLY THREADED (10 MM SMOOTH SHAFT PROXIMALLY), TITANIUM SCREW FROM A STANDARD POSTERIOR CERVICAL FIXATION SET (MOUNTAINEER [DEPUY SYNTHES SPINE, RAYNHAM, MASSACHUSETTS, USA]). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A CASE OF AN (B)(6) YEAR OLD FEMALE (CASE 1), DIED AT 17 MONTHS FROM SEQUELA OF THE PRIMARY TRAUMA, BUT HAD FUSED AFTER A SUCCESSFUL AOTSF PRIOR TO DEATH. A CASE OF A (B)(6) YEAR OLD MALE (CASE 2) HAD A SUCCESSFUL AOTSF. AT 48-MONTH FOLLOW-UP, THE AOTSF CONSTRUCT SHOWED EVIDENCE OF SCREW LOOSENING. THERE WAS A LACK OF FUSION IN THE OCCIPUT TO C1 SEGMENT. CURRENTLY, THE PATIENT IS BEING MONITORED CONSERVATIVELY BECAUSE HE IS ASYMPTOMATIC FROM THE HARDWARE FAILURE. A CASE OF A (B)(6) YEAR OLD FEMALE (CASE 3) AOTSF WAS NOT SUCCESSFUL AS EVIDENCED ON INTRAOPERATIVE CT IMAGING DEPICTING THE SCREWS WITHOUT CAPTURE OF THE OCCIPITAL CONDYLE. THE FIXATION WAS REVISED TO A STANDARD ROD/PLATE/SCREW CONSTRUCT SUCCESSFULLY. THE PATIENT REMAINED NEUROLOGICALLY INTACT AT 48-MONTH FOLLOW-UP. A CASE OF A (B)(6) YEAR OLD MALE (CASE 4), AOTSF, WAS NOT SUCCESSFUL. THE FIXATION WAS REVISED TO A STANDARD ROD/PLATE/SCREW CONSTRUCT. AT 18-MONTH FOLLOW-UP, THE PATIENT HAS REGAINED CONSCIOUSNESS AND DISCLOSED SIGNIFICANT IMPROVEMENT IN ALL EXTREMITIES. FUSION HAS OCCURRED. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE NONCANNULATED FULLY THREADED OR PARTIALLY THREADED (10 MM SMOOTH SHAFT PROXIMALLY), TITANIUM. THIS REPORT IS FOR ONE (1) UNK SCREWS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981412 UNKNOWN SCREWS SCREW, FIXATION, BONE HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1