BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MONO/POLYAXIAL SCREWS

    MDR report key: 12456272 · Received September 10, 2021

    Report

    Report Number
    1526439-2021-01964
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Report Date
    August 13, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREWS FOR VIPER 2/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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: TINELLI M, ET AL. (2014), CORRECT POSITIONING OF PEDICLE SCREWS WITH A PERCUTANEOUS MINIMAL INVASIVE SYSTEM IN SPINE TRAUMA, ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, VOLUME 100, PAGES 389-393, (GERMANY) THIS STUDY HYPOTHESIZE THAT A PERCUTANEOUS MINIMAL INVASIVE DORSAL STABILIZATION SYSTEM ALLOWS SHORT OPERATING TIMES WITH CORRECT SCREW POSITIONING. BETWEEN MAY 2009 AND MARCH 2011, 121 PATIENTS WITH 131 FRACTURES OF A THORACIC AND/OR LUMBAR VERTEBRA WHO UNDERWENT A DORSAL STABILIZATION WITH THE MINIMALLY INVASIVE POLYAXIAL PEDICLE SCREW SYSTEM (UNKNOWN DEPUY SPINE VIPER 2) WERE INCLUDED IN THE STUDY. THERE WERE 52 WOMEN AND 69 MEN WITH A MEAN AGE OF 56.7 YEARS (RANGE 10 TO 88). INTRA-OPERATIVELY, FLUOROSCOPY WAS USED FOR SCREW POSITIONING. A TOTAL OF 682 SCREWS WERE PLACED IN 121 PATIENTS. IN 33 PATIENTS, VERTEBROPLASTY WAS ALSO PERFORMED AND 61 PATIENTS REQUIRED VENTRAL STABILIZATION WHICH WAS PERFORMED DURING THE SAME OPERATION IN 15 PATIENTS AND WITHIN 1 WEEK AFTER THE FIRST PROCEDURE FOR THE OTHER PATIENTS. 15 PATIENTS REQUIRED LAMINECTOMY. AFTER THE SURGERY, THE NEUROLOGICAL STATE OF THE PATIENT WAS EVALUATED IMMEDIATELY BY THE SURGEON AND ON THE FOLLOWING DAY, ALL PATIENTS WERE EXAMINED USING A CT-SCAN WITH 1 MM LAYER AND THE SCREW POSITIONS WERE CHECKED AND EVALUATED. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD COMPLETE REMISSION OF NEUROLOGICAL DISABILITY AFTER THE PROCEDURE DESPITE IMMEDIATE LAMINECTOMY AFTER THE PERCUTANEOUS PROCEDURE. 1 PATIENT HAD REVISION SURGERY BECAUSE OF LOCAL SUBCUTANEOUS HAEMATOMA BUT WITHOUT ANY CHANGING OF THE IMPLANTS. A (B)(6) PATIENT HAD A MALPOSITIONED L3 RIGHT SCREW 1.2 MM MEDIAL. A (B)(6) PATIENT HAD A MALPOSITIONED L5 LEFT SCREW 1MM MEDIAL. A (B)(6) PATIENT HAD A MALPOSITIONED S1 LEFT SCREW MEDIAL INTRAARTICULAR L5/S1. A (B)(6) PATIENT HAD A MALPOSITIONED TH4 RIGHT SCREW 4 MM MEDIAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH12 RIGHT SCREW 1 MM LATERAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH 11 RIGHT SCREW 3.2 MM MEDIAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH11 LEFT SCREW 4.3 MM LATERAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH2 RIGHT SCREW 1 MM LATERAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH4 AND TH6 LEFT SCREWS 1.5MM LATERAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH6 RIGHT SCREW 1MM LATERAL. AN (B)(6) PATIENT HAD A MALPOSITIONED TH8 LEFT SCREW 1 MM MEDIAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH11 RIGHT SCREW 2.2 MM LATERAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH6 SCREW 1 MM LATERAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH6 LEFT SCREW 2.6 MM MEDIAL. A (B)(6) PATIENT HAD A MALPOSITIONED TH7 RIGHT SCREW 2.7 MM MEDIAL. THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE MONO/POLYAXIAL SCREWS FOR VIPER 2. IT CAPTURES THE (B)(6) PATIENT WITH A MALPOSITIONED TH4 AND TH6 LEFT SCREWS. THIS IS REPORT 7 OF 17 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353765 UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR