BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM

    MDR report key: 19696861 · Received July 8, 2024

    Report

    Report Number
    1526439-2024-01781
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREWS: EXPEDIUM/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:HAMMAD A, WIRRIES A, EBERL J, GEIGER F. DEROTATION SCREWS PROVIDE NO ADVANTAGE OVER POLYAXIAL SCREWS REGARDING CORONAL & SAGITTAL CORRECTION IN THORACIC CURVES OF AIS PATIENTS. EUR SPINE J. 2022 NOV;31(11):3029-3035. DOI: 10.1007/S00586-022-07377-7. EPUB 2022 SEP 17. PMID: 36115906. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO COMPARE TWO TECHNIQUES FOR THORACIC APICAL DEROTATION; ONE USING CONVENTIONAL REDUCTION SCREWS (SINGLEINNIE¿SI) AND ONE REQUIRING SPECIAL DEROTATION SCREWS THAT CAN BE CONVERTED TO MONOAXIAL SCREWS TO ENHANCE DOROTATION (DUAL-INNIE¿DI) FOR CORONAL AND SAGITTAL CORRECTION. A TOTAL OF 200 PATIENTS (MALE 21 AND FEMALES 179) WITH THORACIC AIS HAVE BEEN INCLUDED. IN THE SI-GROUP (N=127) THE CONVEX ROD WAS APPLIED FIRST. VERTEBRAL DEROTATION WAS DONE BY TRANSLATION TO THE CONCAVE ROD WITH THE CONVEX ROD BEING IN PLACE AND CENTER OF ROTATION (COR). IN THE DI-GROUP (N=73) CORRECTION STARTED WITH TRANSLATION ON THE CONCAVE SIDE AS WELL BUT NOW FOLLOWED BY DEROTATION AROUND THE CONCAVE ROD USING THE DI-MECHANISM. ALL SCREWS WERE PART OF THE EXPEDIUM SYSTEM (DEPUY). SO, RODS, TOOLS AND OTHER EQUIPMENT WERE THE SAME. THE FOLLOW-UP PERIOD WAS AT LEAST 1 YEAR FOR ALL PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN DEPUY SPINE EXPEDIUM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: EXPEDIUM. (QTY 7): 3 PATIENTS HAD WOUND INFECTION AND NO INTERVENTION WAS REPORTED. 4 PATIENTS HAD WOUND HEALING DISTURBANCES AND NO INTERVENTION WAS REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM. (QTY 9): 9 PATIENTS HAD SCREW LOOSENING AND NO INTERVENTION WAS REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - RODS: EXPEDIUM. (QTY 1): 1 PATIENT HAD ROD BREAKAGE AND NO INTERVENTION WAS REPORTED. THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREWS: EXPEDIUM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152041 UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown