BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE

    MDR report key: 6633969 · Received June 12, 2017

    Report

    Report Number
    3000270450-2017-10194
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    April 26, 2017
    Report Date
    May 16, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDQ
    PMA / PMN Number
    K992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. UDI# (B)(4). INCIDENT OCCURRED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER CONTACT NUMBER (B)(6). DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR STERILE PART# 611.105.01S, LOT# 9844265. NON-STERILE PART# 611.105.01, LOT# P231585. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEB 26, 2016, EXPIRY DATE: FEB 01, 2026. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTER THAT ON (B)(6) 2017, DURING THE SURGERY, THE CERCLAGE CABLE BROKE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTER THAT ON (B)(6) 2016, DURING THE SURGERY, THE CERCLAGE CABLE BROKE. NO SURGICAL DELAY WAS REPORTED. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) 1.7MM COCR CABLE WITH TI CRIMP 750MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415884 1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ SYNTHES SELZACH 9844265

    Patients

    Seq Age Sex Outcome Treatment
    1