BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFRAME ANGLED ROD HOLDER

    MDR report key: 6590382 · Received May 25, 2017

    Report

    Report Number
    3003875359-2017-10252
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    April 27, 2017
    Report Date
    April 27, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FQP
    UDI-DI
    07611819098930
    PMA / PMN Number
    K993314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. PRODUCT CODE XXX USED TO CAPTURE PRODUCT CODE FQP. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: FEBRUARY 05, 2013. 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. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THAT THERE IS NO ALLEGATION AGAINST THIS DEVICE AND IT WILL BE REPORTED AS CONCOMITANT. 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)(4) AS FOLLOWS: IT WAS REPORTED THAT DURING A PRIMARY SPINE SURGERY ON (B)(6) 2017, IT WAS NOT POSSIBLE TO INSERT THE FLEX-ARM INSIDE THE SYNFRAME GUIDING TUBE. ADDITIONALLY IT WAS NOT POSSIBLE TO LOCK THE FLEX-ARM. THE SURGEON HAD TO CHANGE HIS PROCEDURE AND THE PATIENT WAS NOT IMPLANTED WITH A CAGE. THE PATIENT MAY HAVE TO COME BACK FOR A NEW INTERVENTION. THE SURGERY WAS PROLONGED ABOUT FIFTEEN (15) MINUTES BUT THERE WAS NO PATIENT HARM. NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME AND CONDITION. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371650 SYNFRAME ANGLED ROD HOLDER LAMP, OPERATING ROOM FQP SYNTHES HAGENDORF 8236588 07611819098930

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention