BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 6.35 SET SCREWS

    MDR report key: 6330149 · Received February 14, 2017

    Report

    Report Number
    1526439-2017-10122
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 19, 2017
    Report Date
    January 19, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT INFORMATION NOT AVAILABLE. A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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

    FIRST SURGERY (B)(6) 2015 DUE TO AN L1 FRACTURE. IMPLANTS WAS PLACED TH11-L2. X-RAY 3 MONTH LATER IS OK. X-RAY 8 MONTH LATER SHOWS THAT THE SET SCREW IN LEFT L2 HAS LOOSENED FROM THE SCREW. THE PATIENT CAN DESCRIBE THAT SHE, DURING WORK DUTY, FELT THAT SOMETHING BROKE IN HER BACK. AFTER THAT INCIDENT SHE HAD BACK PAIN. THE PAIN HAS DECLINED GRADUALLY. WHEN THEY COULD SEE THAT THE SET SCREW HAS LOOSENED AND THE PATIENT HAS PAIN, THEY DECIDE TO REOPERATE AND REMOVE THE IMPLANTS. DURING SURGERY THEY NOTICE THAT THE SCREW IN LEFT L1 IS BROKEN. THE TIP OF THE SCREW IS LEFT IN BECAUSE IT'S DEEP IN THE PEDICLE. IT TOOK SOME EXTRA TIME(15 MIN) AND ALSO EXTRA X-RAY TO FIND THE LOOSE SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111103 EXPEDIUM 6.35 SET SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R