BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: 7.3 MM CANNULATED

    MDR report key: 14597374 · Received June 3, 2022

    Report

    Report Number
    8030965-2022-03675
    Event Type
    Injury
    Date Received
    June 3, 2022
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW/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. 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: MULLIS, B.H., AND SAGI, H.C. (2008), MINIMUM 1-YEAR FOLLOW-UP FOR PATIENTS WITH VERTICAL SHEAR SACROILIAC JOINT DISLOCATIONS TREATED WITH ILIOSACRAL SCREWS: DOES JOINT ANKYLOSIS OR ANATOMIC REDUCTION CONTRIBUTE TO FUNCTIONAL OUTCOME, JOURNAL OF ORHTOPEDIC TRAUMA, VOL. 22, PAGES 293-298 (USA). THE OBJECTIVE OF THIS STUDY TO PROSPECTIVELY ANALYZE A HOMOGENOUS GROUP OF TRAUMA PATIENTS WITH PURE SACROILIAC (SI) JOINT DISLOCATIONS TREATED WITH ILIOSACRAL SCREWS (ISS), WITH SPECIFIC ATTENTION TO FUNCTIONAL OUTCOME AND ITS CORRELATION WITH THE PRESENCE OR ABSENCE OF SI JOINT ANKYLOSIS AND QUALITY OF REDUCTION. BETWEEN 1995 AND 2004, 23 PATIENTS WHO WERE SKELETALLY MATURE WITH TRAUMATIC VERTICAL SHEAR PELVIC INJURIES ASSOCIATED WITH A PURE SI JOINT DISLOCATION UNDERWENT CLOSED OR OPEN REDUCTION IN THE SUPINE OR PRONE POSITION AND INSERTION OF A SINGLE ISS PLACED PERCUTANEOUSLY FOR THE FIXATION OF THE POSTERIOR RING INJURY USING 7.3-MM, 316-L STAINLESS STEEL CANNULATED SCREWS WITH A 32-MM THREAD (SYNTHES USA, (B)(6)). MINIMUM 1-YEAR RADIOGRAPHIC AND CLINICAL FOLLOW-UP (13¿120 MONTHS) WAS POSSIBLE IN 23 PATIENTS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD AN INITIAL ANATOMIC REDUCTION THAT DISPLACED AND HEALED WITH A RESULTANT MALUNION. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES 7.3-MM SCREW. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978431 UNK - SCREWS: 7.3 MM CANNULATED SCREW, FIXATION, BONE HWC WRIGHTS LANE : SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention