BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

    MDR report key: 7194457 · Received January 16, 2018

    Report

    Report Number
    8030965-2018-50379
    Event Type
    Injury
    Date Received
    January 16, 2018
    Report Date
    November 9, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN 8 DEGREE LORDOTIC ANGLED PEEK IMPLANT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT/EXPLANT IS NOT KNOWN. 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. 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. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE LEE. C-S., PARK. S-J., CHUNG. S-S., LEE. J-Y., YUM. T-H., SHIN. S-K. (2016). MINI-OPEN ANTERIOR LUMBAR INTERBODY FUSION COMBINED WITH LATERAL LUMBAR INTERBODY FUSION IN CORRECTIVE SURGERY FOR ADULT SPINAL DEFORMITY. ASIAN SPINE J, 10(6), P.1023-1032. SOUTH KOREA. THE PURPOSE OF THE STUDY WAS TO INTRODUCE THE TECHNIQUES AND SURGICAL OUTCOMES OF MINI-OPEN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) IN COMBINATION WITH LATERAL LUMBAR INTERBODY FUSION (LLIF) AT THE MOST CAUDAL SEGMENTS OF THE SPINE AS TREATMENT OF ADULT SPINAL DEFORMITY. THE STUDY INCLUDED 32 PARTICIPANTS ALL RANGING IN BETWEEN THE AGES OF 53 AND 85. THE GROUP CONSISTED OF 26 WOMEN AND 6 MEN WITH EITHER A PREOPERATIVE DIAGNOSES OF LUMBAR DEGENERATIVE KYPHOSIS (LDK) OR LUMBAR DEGENERATIVE KYPHOSCOLIOSIS (LDKS). A CORONAL COBB¿S ANGLE (CCA) OF 10 WAS USED AS THE CRITERION FOR DISTINGUISHING LDK AND LDKS. EACH PATIENT¿S OPERATION WAS PERFORMED IN 2 PARTS WITHIN THE INTERVAL OF 1 WEEK. EACH PROCEDURE INCLUDED FUSION TO THE S1 USING BILATERAL ILIAC SCREWS. MINI-OPEN ALIF AT THE L5-S1 AND OR L4-5 LEVELS WERE PERFORMED AND FOLLOWED BY A LLIF. THE ALIF PROCEDURE WAS CARRIED OUT VIA A RETROPERITONEAL APPROACH AFTER A MIDLINE SKIN INCISION. AFTER DISCECTOMY, EACH PATIENT WAS IMPLANTED WITH THE LARGEST POSSIBLE 8 DEGREE LORDOTIC-ANGLED POLYETHERETHERKETONE (SYNCAGE; SYNTHES INC., (B)(4)). THE LLIF PROCEDURE WAS PERFORMED IN A SIMILAR WAY, BUT A CLYDESDALE POLYETHERETHERKETONE WAS USED IN PLACE OF THE SYNTHES PART. THREE REVISION SURGERIES WERE REQUIRED TO REPAIR EPIDURAL HEMATOMAS WITH PROGRESSIVE NEUROLOGIC DEFICIT IN 2 AND FOR DEEP INFECTION IN 1 PATIENT. TRANSIENT WEAKNESS DEVELOPED IN 4 PATIENTS AND PERSISTENT WEAKNESS IN 1. FIVE (5) PATIENTS DEVELOPED PJK; 3 OF THEM UNDERWENT VERTEBROPLASTY AS TREATMENT AND 2 UNDERWENT NO TREATMENT. LASTLY, 1 PATIENT EXPERIENCED INCISIONAL PSEUDOHERNIA. THREE (3) REVISION SURGERIES TO REPAIR EPIDURAL HEMATOMAS. TWO (2) REVISION SURGERIES FOR DEEP INFECTION IN 1 PATIENT. FOUR (4) PATIENTS EXPERIENCING TRANSIENT WEAKNESS. ONE (1) PATIENT EXPERIENCING PERSISTENT WEAKNESS. FIVE (5) PATIENTS DEVELOPING PJK. ONE (1) PATIENT EXPERIENCING INCISIONAL PSEUDOHERNIA. THIS REPORT IS FOR AN UNKNOWN 8° LORDOTIC-ANGLED POLYETHERETHERKETONE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40084 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention