BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPEDIUM

    MDR report key: 12435344 · Received September 7, 2021

    Report

    Report Number
    1526439-2021-01858
    Event Type
    Injury
    Date Received
    September 7, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN JANUARY 2004 AND DECEMBER 2007. 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. 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

    THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: EXPEDIUM.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GHAHREMAN A, ET AL. (2010), MINIMAL ACCESS VERSUS OPEN POSTERIOR LUMBAR INTERBODY FUSION IN THE TREATMENT OF SPONDYLOLISTHESIS, NEUROSURGERY, VOLUME 66, NUMBER 2, PAGES 296-304, (AUSTRALIA). THE OBJECTIVE OF THE STUDY IS TO COMPARE THE SAFETY AND EFFECTIVENESS OF MINIMAL ACCESS POSTERIOR LUMBAR INTERBODY FUSION (MAPLIF) WITH OPEN POSTERIOR LUMBAR INTERBODY FUSION (OPLIF) IN PATIENTS WITH SPONDYLOLISTHESIS AND RADICULAR PAIN. BETWEEN JANUARY 2004 AND DECEMBER 2007, 52 PATIENTS WITH RADICULAR PAIN RESULTING FROM LUMBAR SPONDYLOLISTHESIS WITH A SLIP OF LESS THAN 50 PERCENT WHO UNDERWENT EITHER MAPLIF OR OPLIF WERE INCLUDED IN THE STUDY. IN THE MAPLIF GROUP, THERE WERE 12 MEN AND 13 WOMEN WITH A MEDIAN AGE OF 60 YEARS (RANGE, 48-63 YEARS. IN THE OPLIF GROUP, THERE WERE 13 MEN AND 14 WOMEN WITH A MEDIAN AGE OF 53 (RANGE, 40-61 YEARS). BOTH GROUPS RECEIVED THE SAME IMPLANTS AND INSTRUMENTATIONS WHICH INCLUDE THE UNKNOWN DEPUY SPINE EXPEDIUM POLYAXIAL PEDICLE SCREWS AND A COMPETITOR¿S INTERBODY SPACER. PATIENTS RECEIVED THE SAME POSTOPERATIVE MANAGEMENT. PATIENTS WERE ENCOURAGED TO WALK, BEGINNING ON THE FIRST POSTOPERATIVE DAY. ROUTINE CLINICAL FOLLOW-UP, CHECKING FOR COMPLICATIONS AND RECOVERY, WAS CONDUCTED AT 6 WEEKS, 3 MONTHS, AND 6 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD FAILURE OF FUSION WITH SUBSEQUENT FRACTURE OF A SCREW, WHICH WAS TREATED NONOPERATIVELY. 1 PATIENT HAD RECURRENT LEG PAIN OWING TO THE PROGRESSION OF ADJACENT SEGMENT DISEASE. THIS WAS MANAGED WITH TRANSFORAMINAL INJECTION OF CORTICOSTEROIDS, AND IT SUBSEQUENTLY SETTLED. THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE EXPEDIUM POLYAXIAL PEDICLE SCREWS. THIS REPORT IS FOR ONE (1) UNKNOWN MONO/POLYAXIAL SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331424 UNK - CONSTRUCTS: EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention