BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - MONO/POLYAXIAL SCREWS: VIPER

    MDR report key: 13793863 · Received March 17, 2022

    Report

    Report Number
    1526439-2022-00406
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: THIS REPORT IS FOR AN UNKNOWN VIPER MONO/POLYAXIAL SCREWS/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: MELEIS A., ET AL (2021) SINGLE-CENTER OUTCOMES FOR PERCUTANEOUS PEDICLE SCREW FIXATION IN METASTATIC SPINAL LESIONS: CAN SPONTANEOUS FACET FUSION OCCUR?, NEUROSURG FOCUS VOLUME 50 (5), PAGES 1-7 (USA). THIS SINGLE-CENTER, DESCRIPTIVE, RETROSPECTIVE STUDY AIMS TO REPORT OUTCOMES OF PERCUTANEOUS STABILIZATION USING CEMENT AUGMENTATION OF PEDICLE SCREWS IN THE MANAGEMENT OF SPINAL METASTASIS AND TO PROVIDE AN ANALYSIS OF THE RADIOGRAPHIC EVALUATION OF HARDWARE INTEGRITY AND FUSION. BETWEEN APRIL 2015 AND AUGUST 2019, 74 PATIENTS (35 FEMALES AND 39 MALES) WITH NEOPLASTIC SPINAL INSTABILITY WHO UNDERWENT PERCUTANEOUS INSTRUMENTED SPINAL STABILIZATION WITH CEMENT AUGMENTATION OF FENESTRATED PEDICLE SCREWS WITH CLINICAL, RADIOLOGICAL FOLLOW-UP FOR AT LEAST 6 WEEKS POSTOPERATIVELY WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, VIPER FENESTRATED SCREWS (DEPUY SYNTHES) AND VERTAPLEX BONE CEMENT (STRYKER) WERE USED. PATIENTS WERE EVALUATED WITHIN 1 MONTH OF SURGERY TO ASSESS PAIN SCALE AND POSTOPERATIVE CHECKS. INDIVIDUALS WERE FOLLOWED UP AT 3 AND 6 MONTHS POSTOPERATIVELY AND ANNUALLY AFTERWARD. THE MEDIAN LENGTH OF CLINICAL FOLLOW-UP WAS 5 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT HAD A SURGICAL SITE MUSCULAR HEMATOMA. 27 PATIENTS DEMONSTRATED NONFUSION. THREE PATIENTS HAD HARDWARE FAILURE: ONE WAS INVOLVED IN A CAR ACCIDENT THAT CAUSED A ROD FRACTURE REQUIRING OPERATIVE REPAIR, ANOTHER WAS FOUND TO HAVE A BROKEN SCREW 18 MONTHS FOLLOWING THE INITIAL OPERATION, AND THE LAST PATIENT HAD LUCENCY SURROUNDING ONE OF THE SCREWS 3 MONTHS POSTOPERATIVELY. THE LATTER TWO DID NOT REQUIRE SURGICAL INTERVENTION AS THE PATIENTS WERE ASYMPTOMATIC. THIS REPORT IS FOR UNKNOWN DEPUY SPINE VIPER MONO/POLYAXIAL SCREWS. THIS REPORT CAPTURES THE REPORTED EVENT OF ONE PATIENT WHO HAD HARDWARE FAILURE: ONE WAS FOUND TO HAVE A BROKEN SCREW 18 MONTHS FOLLOWING THE INITIAL OPERATION. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259573 UNK - MONO/POLYAXIAL SCREWS: VIPER ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown