BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: 2.4 MM AND 3.0 MM HEADLESS COMPRESSION

    MDR report key: 14598336 · Received June 3, 2022

    Report

    Report Number
    8030965-2022-03687
    Event Type
    Injury
    Date Received
    June 3, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN 2.4 MM/3.0 MM HEADLESS COMPRESSION SCREW /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE(S) OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN 2010 AND 2012. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MELIBOSKY F., ET AL (2021) FOUR-CORNER FUSION WITH LOCKING DORSAL CIRCULAR PLATE VERSUS HEADLESS COMPRESSION SCREWS: A CLINICO-RADIOLOGICAL COMPARATIVE STUDY, REV IBERAM CIR MANO VOLUME 49(2), PAGES E105¿E114 (CHILE). THIS COMPARATIVE STUDY AIMS TO REPORT THE EXPERIENCE OF THE AUTHORS WITH FOUR-CORNER FUSION USING A RADIOLUCENT LOCKING DORSAL CIRCULAR PLATE (XPODE®, TRIMED INC., SANTA CLARITA, CA, US), AND TO COMPARE IT WITH ANOTHER FIXATION METHOD (3.0-MM CANNULATED HEADLESS COMPRESSION SCREWS [HCSS], SYNTHES, SOLOTHURN, SWITZERLAND) REGARDING CONSOLIDATION, FUNCTIONAL OUTCOMES, AND COMPLICATION RATES. IN TOTAL, 17 SUBJECTS WERE INCLUDED; 8 PATIENTS WERE OPERATED ON FROM 2010 TO 2012 WITH OSTEOSYNTHESIS USING 2 HCSS, (3.0 MM CANNULATED HEADLESS COMPRESSION SCREWS [HCSS], SYNTHES, SOLOTHURN, SWITZERLAND) AND 9 PATIENTS WERE OPERATED ON BETWEEN 2011 AND 2014 WITH A RADIOLUCENT LOCKING DORSAL CIRCULAR PLATE (XPODE®, TRIMED INC., SANTA CLARITA, CA, US), MADE OF A SYNTHETIC POLYMER CALLED POLYETHER-ETHER-KETONE (PEEK). THE MEAN AGE IN THE FIRST GROUP WAS 45 YEARS (RANGE: 32¿ 64 YEARS) AND THE AVERAGE FOLLOW-UP PERIOD WAS OF 18 MONTHS. THIS GROUP CONSISTED OF SIX MEN AND TWO WOMEN. IN THE SECOND GROUP, THE MEAN AGE WAS 40 YEARS (RANGE: 18 62 YEARS). THIS GROUP CONSISTED OF EIGHT MEN AND ONE WOMAN. THE AVERAGE FOLLOW-UP PERIOD WAS OF 12 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: FAILURE OF THE OSTEOSYNTHESIS. A CASE OF OSTEOLYSIS, WHICH DID NOT RESULT IN NON-UNION. A CLINICALLY-ASYMPTOMATIC PATIENT PRESENTED MIGRATION OF ONE OF THE CAPITATE-LUNATE SCREWS ON THE CONTROL RADIOGRAPH TAKEN AT SIX MONTHS; SINCE THERE WAS A RISK OF INVOLVEMENT OF THE RADIOCARPAL ARTICULAR SURFACE, A NEW SURGERY WAS REQUIRED FOR THE REMOVAL OF THE OSTEOSYNTHESIS MATERIAL NINE MONTHS AFTER THE FIRST PROCEDURE. FAILURE OF THE OSTEOSYNTHESIS. A CASE OF OSTEOLYSIS, WHICH DID NOT RESULT IN NON-UNION, WITH AND RADIOLUNATE JOINT WEAR. PATIENT PRESENTED PERSISTENT PAIN THAT DID NOT SUBSIDE WITH REHABILITATION, SO IT WAS DECIDED TO PERFORM A TOTAL WRIST ARTHRODESIS, WHICH IS STILL PENDING. THE MEAN FLEXION-EXTENSION ROM AMONG THE HCS GROUP WAS OF 68°, WITH AN AVERAGE FLEXION OF 38.1° (RANGE: 20°¿45°) AND AN AVERAGE EXTENSION OF 29.7° (RANGE: 20°¿40°). THIS REPORT IS FOR UNKNOWN SYNTHES 3.0-MM CANNULATED HEADLESS COMPRESSION SCREWS (HCSS). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801799 UNK - SCREWS: 2.4 MM AND 3.0 MM HEADLESS COMPRESSION SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention