BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ARCH LAMINOPLASTY MINIPLATE/SCREWS

    MDR report key: 14641576 · Received June 9, 2022

    Report

    Report Number
    8030965-2022-03829
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    August 31, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    NQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA-510K: THIS REPORT IS FOR AN UNKNOWN TITANIUM MINIPLATES (ARCH FIXATION SYSTEM/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: 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. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GUO Q., ET AL (2021) CLINICAL AND RADIOLOGICAL OUTCOMES OF TWO MODIFIED OPEN-DOOR LAMINOPLASTIES BASED ON A NOVEL PARASPINAL APPROACH FOR TREATMENT OF MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY, SPINE VOLUME 47, NUMBER 6, PP E222¿E232 (B)(6). THIS STUDY AIMS TO FIND OUT IF PRESERVING EXTENSORS THROUGH A NOVEL PARASPINAL APPROACH COULD PREVENT MUSCLE ATROPHY AND RETROSPECTIVELY ANALYZED AND COMPARED DATA OF MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY (MCSM). PATIENTS TREATED WITH EITHER ONE OF MODIFIED LAMINOPLASTY (LP) OR CONCURRENT CONVENTIONALLAMINOPLASTY (LP). FROM JULY 2015 TO MAY 2016, 46 CONSECUTIVE PATIENTS DIAGNOSED AS MCSM IN TONGJI HOSPITAL WERE RANDOMLY DIVIDED INTO TWO GROUPS AND UNDERWENT MODIFIED LP PRESERVING DEEP EXTENSORS ON THE HINGE SIDE (GROUP A) AND CONVENTIONAL LP (GROUP B) RESPECTIVELY. IN ADDITION, 5 YEARS EARLIER, FROM NOVEMBER 2010 TO NOVEMBER 2011, 46 CONSECUTIVE MCSM PATIENTS WERE RANDOMLY GROUPED AND UNDERWENT MODIFIED LP PRESERVING BILATERAL DEEP EXTENSORS (GROUP C) AND CONVENTIONAL LP (GROUP D) IN TONGJI HOSPITAL. GROUP B (OR D) WAS SET AS A CONCURRENT CONTROL TO GROUP A (OR C). DURING SURGERY, THE PARASPINAL APPROACH WAS USED TO EXPOSE THE LAMINA IN MODIFIED GROUPS THE EXPANDED SPINAL CANAL WAS MAINTAINED USING APPROPRIATE-SIZED TITANIUM MINIPLATES (ARCH FIXATION SYSTEM, DEPUY SYNTHES, SWITZERLAND) WHICH WERE SECURED WITH SCREWS. THE CONTROL GROUP UNDERWENT CONVENTIONAL PROCEDURE AS DESCRIBED, ALSO USING THE ARCH MINIPLATES TO MAINTAIN SPINAL CANAL ENLARGEMENT WITHOUT SPINOUS PROCESS OSTEOTOMY. PATIENTS RETURNED FOR OUTPATIENT EXAMINATIONS 3, 6, 12, AND 24 MONTHS AFTER SURGERY. A TOTAL OF 89 PATIENTS WERE FOLLOWED-UP FOR AT LEAST 24 MONTHS INCLUDING 44 OF 46 WHO UNDERWENT MODIFIED LP PRESERVING DEEP EXTENSORS ON THE HINGE SIDE (GROUP A) OR CONVENTIONAL LP (GROUP B), AND 45 OF 46 WHO UNDERWENT MODIFIED LP PRESERVING BILATERAL DEEP EXTENSORS (GROUP C) OR CONVENTIONAL LP (GROUP D). THE AVERAGE FOLLOW-UP DURATION WAS SIMILAR AMONG FOUR GROUPS: 33.05 MONTHS IN GROUP A (RANGE, 28¿38MONTHS), 31.55 MONTHS IN GROUP B (RANGE, 28¿38 MONTHS), 33.02 MONTHS GROUP C (RANGE, 26¿ 42 MONTHS), 32.52 MONTHS GROUP D (RANGE, 27¿44 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: INCIDENCE OF C5 PALSY. INCIDENCE OF NEW AXIAL PAIN. LOSS OF C2-C7 COBB ANGLE. POST-LP DEEP EXTENSOR ATROPHY. DEEP EXTENSOR ATROPHY FOR THREE LP TECHNIQUES MENTIONED IN THIS ARTICLE WERE SHOWN IN FIGURE 5A¿F AND FIGURE 6A¿F, RESPECTIVELY. NO SIGNIFICANT IMPROVEMENT IN TOTAL CSA OF POSTERIOR DEEP EXTENSORS ON THE OPEN SIDE COMPARED TO ITS CONTROL. THIS REPORT IS FOR UNKNOWN SYNTHES TITANIUM MINIPLATES (ARCH FIXATION SYSTEM). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156015 UNK - CONSTRUCTS: ARCH LAMINOPLASTY MINIPLATE/SCREWS ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention