BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INSERTION INSTRUMENTS

    MDR report key: 10508962 · Received September 9, 2020

    Report

    Report Number
    1526439-2020-01627
    Event Type
    Injury
    Date Received
    September 9, 2020
    Report Date
    August 12, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN INSERTION INSTRUMENT/UNKNOWN LOT. PART AND LOT NUMBER 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: UMANA GE, ET AL. (2020), SAFETY AND EFFICACY OF NAVIGATED TROCARLESS PEDICLE SCREW PLACEMENT: TECHNICAL NOTE, INTERDISCIPLINARY NEUROSURGERY, VOLUME 21, PAGE 1-7, (ITALY). THIS STUDY AIMS TO DESCRIBE A PERCUTANEOUS PEDICLE SCREW FIXATION PERFORMED WITH A NOVEL NAVIGATED ¿ONE-STEP¿ SYSTEM, UNDERLINING THE SAFETY AND EFFECTIVENESS OF SUCH TECHNIQUE. BETWEEN DECEMBER 2014 AND JUNE 2018, 43 PATIENTS WHO UNDERWENT SPINAL STABILIZATION SURGERY WITH PEDICLE SCREWS AND TITANIUM RODS PLACEMENT WERE INCLUDED IN THE STUDY. THERE WERE 21 MALES AND 22 FEMALES WITH A MEAN AGE OF 59.19 YEARS (RANGE 19-79 YEARS). TWELVE (12) OUT OF 43 PATIENTS UNDERWENT PERCUTANEOUS STABILIZATION WITH PEDICLE SCREWS WITH STANDARD FLUOROSCOPY TECHNIQUE (GROUP A); 31 OUT OF 43 PATIENTS UNDERWENT PERCUTANEOUS STABILIZATION WITH PEDICLE SCREWS USING THE INTRAOPERATIVE NAVIGATION SYSTEM (GROUP B). AN UNKNOWN DEPUY SPINE VIPER PRIME ¿ONE STEP¿ SYSTEM INSTRUMENTATION WAS USED FOR PATIENTS IN GROUP B. A TOTAL OF 230 PEDICLE SCREWS WERE IMPLANTED AND WERE EVALUATED DURING A 43-MONTH PERIOD. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD A SCREW AT RISK IN THE THORACIC SPINE. IT IS A MEDIALLY PROTRUDING SCREW FOR MORE THAN 4 MM, OR A SCREW THAT LATERALLY OR ANTERIORLY ARE IN CONTACT WITH ANATOMICAL STRUCTURES SUCH AS THE AORTA, THE TRACHEA, AND THE ESOPHAGUS. 5 SCREWS IN THE THORACIC SPINE HAD AN INDETERMINATE MISPLACEMENT. THE SCREWS PROTRUDE MEDIALLY BETWEEN 2 AND 4 MM OR ARE LATERALLY OR ANTERIORLY ADJACENT (DISTANCE 1¿2 MM BETWEEN THE TIP OF THE SCREW AND THE ORGAN) TO THE ANATOMICAL STRUCTURES. 1 SCREW IN THE LUMBAR SPINE HAD AN INDETERMINATE MISPLACEMENT. THE SCREW PROTRUDES MEDIALLY BETWEEN 2 AND 4 MM OR ARE LATERALLY OR ANTERIORLY ADJACENT (DISTANCE > 1¿2 MM BETWEEN THE TIP OF THE SCREW AND THE ORGAN) TO THE ANATOMICAL STRUCTURES. 2 SCREWS IN THE THORACIC SPINE HAD A BENIGN MISPLACEMENT. THE SCREWS GET PAST THE CORTICAL WALL BUT DO NOT PUT ANY STRUCTURE AT RISK. 1 SCREW IN THE LUMBAR SPINE HAD A BENIGN MISPLACEMENT. THE SCREWS GET PAST THE CORTICAL WALL BUT DO NOT PUT ANY STRUCTURE AT RISK. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE VIPER PRIME SYSTEM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971165 UNKNOWN INSERTION INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention