BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS

    MDR report key: 9243684 · Received October 28, 2019

    Report

    Report Number
    8030965-2019-69719
    Event Type
    Injury
    Date Received
    October 28, 2019
    Report Date
    October 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GROB, D., RUBELI, M., SCHEIER, H.J.G., AND DVORAK, J. (1992), TRANSLAMINAR SCREW FIXATION OF THE LUMBAR SPINE, INTERNATIONAL ORTHOPAEDICS (SICOT), VOL. 16, PAGES 223-226, (SWITZERLAND). THE AIM OF THIS STUDY IS TO DETERMINE THE INCIDENCE OF FUSION, COMPLICATIONS AND THE RELIEF OF PAIN AFTER TRANSLAMINAR/ TRANSARTICULAR SCREW FIXATION. A TOTAL OF 72 PATIENTS (43 MALE AND 29 FEMALE) WITH AN AVERAGE AGE OF 48.6 YEARS (RANGE 15 TO 81 YEARS) UNDERWENT A TRANSLAMINAR FUSION. SURGERY WAS PERFORMED USING A 3.2 MM AO DRILL BIT AND A 50 TO 54 MM LONG 4.5 MM AO SCREW. THE PATIENTS WERE FOLLOWED UP AFTER A MINIMUM OF ONE YEAR WITH AN AVERAGE OF 24.4 MONTHS (RANGE 12 TO 47 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD PATIENT HAD UNRELIEVED PAIN POST TREATMENT. DIAGNOSTIC INFILTRATION OF THE L4/5 AND L5/S 1 FACET JOINT WITH LOCAL ANAESTHETIC RESULTED IN COMPLETE, BUT TEMPORARY, RELIEF OF PAIN. THERE IS A CALCIFIED POSTEROLATERAL FUSION MASS 30 MONTHS POSTOPERATIVELY. 4 PATIENTS HAD NONUNION WHICH WAS CONFIRMED AT REOPERATION IN 5 SEGMENTS. 4 PATIENTS HAD PAINFUL PSEUDARTHROSIS WHICH NECESSITATES FURTHER OPERATION. 1 PATIENT HAD DISCITIS AT L4/5 LEVEL AFTER NUCLEOTOMY AND SCREW FIXATION; DRAINAGE WAS NEEDED, BUT THE SCREWS WERE FIRM AND WERE NOT REMOVED. 2 PATIENTS HAD INCREASED BACK PAIN AFTER OPERATION, AND IN ONE OF THEM OVER DISTRACTION OF TWO LEVELS MIGHT HAVE BEEN RESPONSIBLE. 3 PATIENTS HAD PAINFUL ROOT IRRITATION. 1 PATIENT HAD WRONG LEVEL FUSION AND A FURTHER OPERATION HAD TO BE CARRIED OUT. 2 PATIENTS HAD DEEP VEIN THROMBOSIS. 1 PATIENT DEVELOPED BRONCHOPNEUMONIA. 2 PATIENTS DEVELOPED URINARY TRACT INFECTIONS. 1 PATIENT HAD DURAL TEAR OCCURRED DURING DECOMPRESSION. 5 PATIENTS HAD LOOSENING OF SCREWS, INDICATED BY A RADIOLUCENT AREA OR CHANGE IN POSITION, 4 OF WHOM SHOWED MOTION AT THE AFFECTED SEGMENT. 5 SCREWS WERE BROKEN. THIS REPORT IS FOR AN UNKNOWN SYNTHES SPINE SCREWS. THIS IS 3 OF 3 FOR REPORT (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040122 UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention