BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 12096103 · Received June 30, 2021

    Report

    Report Number
    1526439-2021-01343
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KIM S.K ET AL (2020), MODIFIED PEDICLE SUBTRACTION OSTEOTOMY FOR OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES, ORTHOPEDIC SURGERY VOLUME 12, NUMBER 2, PAGES 388395 (SOUTH KOREA). DOI:10.1111/OS.12589. THIS RETROSPECTIVE STUDY AIMS TO: EVALUATE PATIENTS WITH OVCF WITH KYPHOTIC DEFORMITY WHO UNDERWENT OUR MODIFIED PEDICLE SUBTRACTION OSTEOTOMY; ANALYZE THE CLINICAL AND RADIOLOGICAL OUTCOMES AND COMPLICATIONS OF THIS OSTEOTOMY; AND FIND OUT THE USEFULNESS OF OUR SPINAL OSTEOTOMY FOR OVCF. BETWEEN NOVEMBER 2003 AND JULY 2012, 20 PATIENTS (11 WOMEN, 9 MEN; MEAN AGE, 66 YEARS [5279 YEARS] DIAGNOSED WITH OVCF AND WHO UNDERWENT MODIFIED PEDICLE SUBTRACTION OSTEOTOMY WERE INCLUDED IN THE STUDY. POSTERIOR FUSION WAS PERFORMED FROM THE TWO LEVELS ABOVE TO THE TWO LEVELS BELOW USING AUTOLOGOUS BONE GRAFTS OBTAINED FROM THE BODY, LAMINA, AND SPINOUS PROCESS AFTER OSTEOTOMY AND INSTRUMENTATION (MOSS-MIAMI, DEPUY, WARSAW, IN, USA; MONARCH, DEPUY SPINE, INC., RAYNHAM, MA, USA). MEAN FOLLOW-UP, 39.6 MONTHS [24111 MONTHS]. THE FOLLOWING COMPLICATIONS WERE REPORTED: A CASE OF A (B)(6) YEAR-OLD WOMAN (PATIENT NO. 2) WITH L1 OSTEOPOROTIC COMPRESSION FRACTURE ACCOMPANYING FUNCTIONAL PARAPLEGIA SHOWING A KYPHOTIC ANGLE OF 23.5 DEGREES. A RADIOGRAPH TAKEN AT 5 YEARS POSTOPERATIVE SHOWS INCREASED KYPHOSIS TO 27.3 DEGREES (16.9-DEGREE CORRECTION LOSS). HOWEVER, THE PATIENTS PAIN RELIEF AND PARTIAL RECOVERY OF FUNCTIONAL PARAPLEGIA WERE MAINTAINED. CT SCAN TAKEN AT 5 YEARS POSTOPERATIVE SHOWING BONE UNION OF THE OSTEOTOMY SITE AND DECOMPRESSION OF THE SPINAL CANAL. A CASE OF (B)(6) YEAR-OLD MALE (PATIENT NO. 10) SHOWING A KYPHOTIC ANGLE OF 30.0 DEGREES. POSTOPERATIVE SHOWS INCREASED KYPHOSIS TO 36.7 DEGREES. A CASE OF A (B)(6) YEAR-OLD WOMAN (PATIENT NO. 20) WITH AN L1 OSTEOPOROTIC COMPRESSION FRACTURE SHOWING A KYPHOTIC ANGLE OF 52.1 DEGREES. THE KYPHOSIS PROGRESSED TO 18.6 DEGREES AT 2 YEARS POSTOPERATIVE. (D) LATERAL PLAIN RADIOGRAPH TAKEN AT 4 YEARS POSTOPERATIVE SHOWING WELL MAINTAINED SAGITTAL CORRECTION WITH KYPHOSIS OF 19.7 DEGREES. A 9.5-DEGREE CORRECTION LOSS AT THE LAST FOLLOW-UP THROUGH PLAIN RADIOGRAPHY. ILEUS OCCURRED IMMEDIATELY POSTOPERATIVELY IN ONE CASE, BUT THE PATIENT RECOVERED WELL WITH CONSERVATIVE TREATMENT AND EARLY AMBULATION USING THE TLSO BRACE. ONE CASE OF CAUDA EQUINA SYNDROME AT 2 DAYS POST-OPERATIVE. WE PERFORMED EMERGENCY OPERATION FOR HEMATOMA REMOVAL AND THE MOTOR GRADE RECOVERED TO FAIR. TWO CASES OF PROXIMAL JUNCTIONAL KYPHOSIS. TWO CASES OF SCREW LOOSENING, BUT IN ALL CASES THE FOLLOW-UP PLAIN RADIOGRAPHS SHOWED A SOLID FUSION, AND THE SCREW LOOSENING DID NOT PROGRESS; THEREFORE, REVISION SURGERY WAS NOT NEEDED. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE MOSS-MIAMI AND UNKNOWN DEPUY SPINE MONARCH. THIS REPORT IS FOR (1) UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES. THIS REPORT IS 1 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989304 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention