BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME LENGTHENER

    MDR report key: 5270548 · Received December 7, 2015

    Report

    Report Number
    3003875359-2015-10516
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Report Date
    November 16, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FQP
    PMA / PMN Number
    PK993314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHETHER OR NOT THE ISSUE OCCURRED DURING A SURGICAL PROCEDURE. THEREFORE, PATIENT INVOLVEMENT CANNOT BE CONFIRMED. DEVICE PRODUCT CODE XXX USED TO REPORT UNAVAILABLE CODE FQP (LAMP, OPERATING ROOM). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. PER FACILITY, THE COMPLAINANT PART WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: AUGUST 5, 1999. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 REPORTED THAT A SYNFRAME LENGTHENER INSTRUMENT IS MISSING SCREWS. THE REPORTING FACILITY HAS NO ADDITIONAL INFORMATION PERTAINING TO THIS EVENT. PATIENT AND/OR SURGICAL INVOLVEMENT IS UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801598 SYNFRAME LENGTHENER LAMP, OPERATING ROOM FQP SYNTHES HAGENDORF 1038600

    Patients

    Seq Age Sex Outcome Treatment
    1