BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN LAG SCREW 10.5X110

    MDR report key: 3184438 · Received June 18, 2013

    Report

    Report Number
    9613350-2013-01639
    Event Type
    Injury
    Date Received
    June 18, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WITH THE INFO GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A ZNN CMN LAG SCREW 10.5X110 ON THE LEFT SIDE ON AN UNK DATE. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2013. DURING SURGERY, THE SURGEON HAD PROBLEMS PULLING OUT THE SCREW WITH THE ZNN CM INSTRUMENTS BECAUSE THE OUTER PART OF THE SCREW WAS DAMAGED. IT WAS FINALLY TAKEN OUT WITH OTHER INSTRUMENTS. IT WAS ALSO REPORTED THAT THE SURGERY WAS PROLONGED BY ABOUT 1-2 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276150 ZNN CMN LAG SCREW 10.5X110 ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDUL... HSB ZIMMER GMBH 2591557

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R