BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MOUNTAINEER

    MDR report key: 19793888 · Received July 22, 2024

    Report

    Report Number
    1526439-2024-01885
    Event Type
    Injury
    Date Received
    July 22, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: MOUNTAINEER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: SECOND MILITARY MEDICAL UNIVERSITY WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CAO B, CHEN J, YUAN B, SUN Y, ZHOU S, ZHAO Y, XU Z, TANG Y, CHEN X. COMPARISON OF THE OUTCOME AFTER ANTERIOR CERVICAL OSSIFIED POSTERIOR LONGITUDINAL LIGAMENT EN BLOC RESECTION VERSUS POSTERIOR TOTAL LAMINECTOMY AND FUSION IN PATIENTS WITH OSSIFICATION OF THE CERVICAL POSTERIOR LONGITUDINAL LIGAMENT: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL. BONE JOINT J. 2023 MAR 15;105-B(4):412-421. DOI: 10.1302/0301-620X.105B4.BJJ-2022-0804.R2. PMID: 36924177. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE THE OUTCOME OF ANTERIOR CERVICAL OSSIFIED POSTERIOR LONGITUDINAL LIGAMENT EN BLOC RESECTION (ACOE) WITH POSTERIOR LAMINECTOMY AND FUSION WITH BONE GRAFT AND INTERNAL FIXATION (PTLF) FOR THE SURGICAL MANAGEMENT OF PATIENTS WITH THIS CONDITION. BETWEEN JULY 2017 AND JULY 2019, 40 PATIENTS AGE BETWEEN 35 AND 70 YEARS; WITH A DIAGNOSIS OF CERVICAL OPLL WERE EQUALLY RANDOMIZED TO UNDERGO SURGERY WITH AN ACOE OR A PTLF. THE CLINICAL AND RADIOLOGICAL RESULTS WERE COMPARED BETWEEN THE TWO GROUPS.THE WIDTH OF THE DISSECTION IS USUALLY LARGER THAN THE WIDTH OF OSSIFIED LIGAMENT, WHICH GUARANTEES THE ABILITY TO FREE AND PRESERVE THE DURA THROUGHOUT THE ENTIRE SEGMENTS WHICH ARE COVERED BY THE OSSIFIED LIGAMENT INCLUDING THAT BEHIND THE MIDPORTION OF THE VERTEBRAL BODIES, AND PREVENT SPINAL CORD INJURY DURING MANIPULATION AND DETACHMENT OF THE FLOATING OSSIFIED LIGAMENT ALLOWING IT TO BE ELEVATED. THE OSSIFIED DURA IS RESECTED AS PART OF THE EN BLOC INCLUDING THE DISEASED SEGMENT AND OSSIFIED LIGAMENT. IF THE PIA MATER IS COMPLETE, AND THERE IS NO CSF LEAK, WE DO NOT REPAIR IT. IF THERE IS A CSF LEAK, WE REPAIR THE DURA WITH A DURA-GUARD PATCH (SYNOVIS LIFE TECHNOLOGIES, USA) TO PREVENT SPINAL CORD INJURY.THE PTLF WAS PERFORMED AS DESCRIBED USING A MOUNTAINEER LATERAL MASS SCREW FIXATION SYSTEM (DEPUY SYNTHES SPINE, USA).THE PATIENTS WERE REVIEWED AT THREE, SIX, 12, AND 24 MONTHS POSTOPERATIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: MOUNTAINEER LATERAL MASS SCREW FIXATION SYSTEM (DEPUY SYNTHES SPINE, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK: CONSTRUCTS: MOUNTAINEER (QTY 10) - 1 PATIENT HAD CEREBROSPINAL FLUID LEAK; ACHIEVED A FAVORABLE OUTCOME AFTER RECURRENT ASPIRATION, PRESSURE DRESSING, AND BED REST. - 5 PATIENT DEVELOPED A C5 PALSY WITH A MEAN TIME TO MOTOR RECOVERY OF TEN MONTHS (6 TO 19). - 4 PATIENTS HAD AXIAL PAIN; RESOLVED UNREMARKABLY WITHOUT SPECIAL INTERVENTION THIS REPORT IS FOR AN UNK - CONSTRUCTS: MOUNTAINEER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119396 UNK - CONSTRUCTS: MOUNTAINEER ORTHOSIS, SPINAL PEDICLE FIXATION MNI MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention