BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM S-LOK POLYAXIAL SCREW

    MDR report key: 4081113 · Received August 29, 2014

    Report

    Report Number
    3005739886-2014-00037
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    August 7, 2014
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADD'L INFO, INCLUDING DATE OF IMPLANTATION AND REVISION, PART AND LOT IDENTITY AND AVAILABILITY OF PRODUCT FOR EVALUATION HAVE BEEN UNSUCCESSFUL. WITHOUT PART AND LOT IDENTITY REVIEW OF MANUFACTURING HISTORY AND LOT SPECIFIC COMPLAINT HISTORY COULD NOT BE PERFORMED. REVIEW OF COMPLAINT HISTORY FOR ALL PART NUMBERS IN THE SLXXXXX FAMILY OF S-LOK POLYAXIAL SCREWS DID NOT REVEAL A TREND FOR REPORTS OF THIS NATURE. NO CONCLUSIONS COULD BE DRAWN AS NO DEVICE OR PART/LOT NUMBER WAS PROVIDED. SHOULD ADD'L INFO BE REC'D A F/U MEDWATCH REPORT WILL BE FILE AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE TWO (2) BROKEN 6.5MM DIAMETER PEDICLE SCREWS FROM L5 AND S1 RESPECTIVELY. THE SCREW FRACTURE WAS APPROXIMATELY 20MM FROM THE TIP OF THE SCREW, IN THE BODY OF THE THREADED PORTION. NO ADD'L INFO HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527731 6.5MM S-LOK POLYAXIAL SCREW MNH, MNI MNH PRECISION SPINE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R