BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCRDRIVERSHAFT F/LOCKCAP F/URS

    MDR report key: 6604338 · Received June 1, 2017

    Report

    Report Number
    2520274-2017-11753
    Event Type
    Injury
    Date Received
    June 1, 2017
    Report Date
    May 4, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN ROD. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THIS REPORT IS FOR ONE (1) UNKNOWN ROD. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: REPORTER FIRST AND LAST NAME. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT A (B)(6) PATIENT WAS PREVIOUSLY OPERATED ON DUE TO SCOLIOSIS. THE DATE OF THE FIRST SURGERY IS UNKNOWN. DURING A CHECKUP THE DOCTOR DETECTED THAT THE PLACED RODS ARE FATIGUED AND DECIDED TO MAKE A CHANGE. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2017. PATIENT CONDITION WAS REPORTED AS OK WITH HIGH RISK. INCIDENT OCCURRED DURING REVISION SURGERY IS CAPTURED UNDER (B)(4). REPORTED CONCOMITANT DEVICES: LOCKING CAP (PART: 04.636.001, QUANTITY: APPROX. 20). THIS REPORT IS FOR ONE (1) UNKNOWN ROD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386018 SCRDRIVERSHAFT F/LOCKCAP F/URS ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention PART# 04.636.001, LOT# UNKNOWN, QUANTITY: APPROX20