BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 12073879 · Received June 28, 2021

    Report

    Report Number
    1030489-2021-00848
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 28, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HSB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. COUNTRY - (B)(6). AGE AT EVENT: THE MEAN AGE OF 19 PATIENT WAS 70.36 YEARS (RANGE 55 YEARS TO 77 YEARS). SEX: 16 FEMALE AND 3 MALE. PATIENT SYMPTOMS KYPHOTIC RECURRENCE AND SHL(SEGMENTAL HEIGHT LOSS) WAS REPORTED. AS CODE WAS NOT AVAILABLE USED IME (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: MOON-SOO HAN, SHIN-SEOK LEE, SEUL-KEE LEE, JAE-WON JANG, BONG JU MOON, JUNG-KIL LEE. SINGLE-STAGE POSTERIOR CIRCUMFERENTIAL STABILIZATION USING DOUBLE SMALL CAGES FOR THE TREATMENT OF THORACIC AND LUMBAR SPINE FRACTURES. WWW.JOURNALS.ELSEVIER.COM/WORLD-NEUROSURGERY. EVENT SUMMARY- IN THIS STUDY, ALTERNATIVE TECHNIQUE FOR PRIMARY TREATMENT AND SALVAGE INVOLVING SINGLE-STAGE THORACIC, THORACOLUMBAR, OR LUMBAR CORPECTOMY FOLLOWED BY RECONSTRUCTION OF THE ANTERIOR COLUMN USING DOUBLE SMALL MESH CAGES AND SUPPLEMENTAL SCREW FIXATION VIA THE POSTERIOR-ONLY APPROACH. ALSO EVALUATE THE OUTCOMES OF THIS TECHNIQUE AND THE POTENTIAL RISK FACTORS FOR A BAD OUTCOME. THE STUDY INCLUDED 19 PATIENTS TREATED AT OUR INSTITUTION BETWEEN (B)(6) 2014 AND (B)(6) 2017 WHO UNDERWENT SINGLE-STAGE CORPECTOMY FOLLOWED BY RECONSTRUCTION OF THE ANTERIOR COLUMN USING DOUBLE SMALL MESH CAGES AND SUPPLEMENTAL SCREW FIXATION VIA THE POSTERIOR-ONLY APPROACH. PATIENT WITH A SINGLE-LEVEL VERTEBRAL BODY FRACTURE WITH SPINAL INSTABILITY, SEGMENTAL KYPHOTIC DEFORMITY, AND NEUROLOGIC DEFICIT CAUSED BY OSTEOPOROTIC FRACTURES, TRAUMA, OR INFECTIVE SPONDYLITIS. PATIENTS WITH MULTILEVEL VERTEBRAL BODY FRACTURES AND THOSE WHO UNDERWENT 12 MONTHS OF CLINICAL OR RADIOLOGIC FOLLOW-UP AFTER SURGERY WERE EXCLUDED FROM THE STUDY. SURGICAL TECHNIQUE- AFTER A CLASSIC MIDLINE POSTERIOR APPROACH TO THE SPINE, THE POSTERIOR ASPECTS OF THE LAMINAE WERE EXPOSED, MINIMALLY EXTENDING TO THE LATERAL SIDE OF THE CORRESPONDING TRANSVERSE PROCESS. POSTERIOR MULTISEGMENTAL FIXATION WAS THEN PERFORMED, USING A SCREW-ROD SYSTEM (CD HORIZON, LEGACY SYSTEM, MEDTRONICS, MEMPHIS, TENNESSEE, USA). IN PATIENTS WITH OSTEOPOROTIC FRACTURES, PEDICLE SCREW FIXATION WITH VERTEBROPLASTY AUGMENTATION WAS PERFORMED.15 PEDICLE SCREWS WERE USUALLY APPLIED 3 LEVELS ABOVE AND 2 LEVELS BELOW THE LEVEL OF THE FRACTURED VERTEBRA DEPENDING ON THE DEGREE OF OSTEOPOROSIS. A TEMPORARY ROD WAS INSERTED AT THE CONTRALATERAL SIDE TO PREVENT UNDESIRABLE MOVEMENT OF THE FRACTURED LEVEL DURING DECOMPRESSION AND VERTEBRAL BODY RESECTION. TWO SMALL MESH CAGES (13 MM; PYRAMESH, MEDTRONICS), WHOSE LENGTHS WERE ADJUSTABLE, WERE CREATED AND FILLED WITH CANCELLOUS BONE FROM THE REMOVED BONE, AS WELL AS SYNTHETIC BONE SUBSTITUTES. FLUOROSCOPY WAS CONDUCTED, FOR CONFIRMING THAT THE 2 CAGES APPEARED ON EITHER SIDE OF THE MIDLINE IN THE ANTEROPOSTERIOR VIEW AND IN THE MIDDLE PORTION (NOT TO ANTERIOR OR POSTERIOR) OF THE LATERAL VIEW. ON RADIOLOGIC FOLLOW-UP EXAMINATION, 3 PATIENTS HAD BONE FUSION GRADE 2 (16%), 8 (42%) HAD GRADE 3, AND 8 (42%) HAD GRADE 4. NONE HAD GRADE 0 OR GRADE 1. THUS FUSION WAS SUCCESSFULLY ACHIEVED IN 16 PATIENTS (84.2%) WITHIN A MEDIAN INTERVAL OF 12 MONTHS (RANGE, 6E13 MONTHS). KYPHOTIC RECURRENCE WAS OBSERVED IN 2 PATIENTS (11%), WHILE SHL WAS OBSERVED IN 1 PATIENT (5%); THE PATIENT WITH SHL ALSO EXPERIENCED KYPHOTIC RECURRENCE. KYPHOTIC RECURRENCE AND SHL OCCURRED AT A MEDIAN INTERVAL OF 18.8 MONTHS (RANGE, 12.3E25.3 MONTHS). THE PATIENT WHO EXPERIENCED BOTH KYPHOTIC RECURRENCE AND SHL SUFFERED FRACTURED RODS 24 MONTHS AFTER SURGERY AND UNDERWENT REOPERATION, WHICH INCLUDED ROD CHANGE AND DUAL ROD APPLICATION. AFTER REOPERATION, THERE WAS NO FURTHER LOSS OF CORRECTION OR SHL DURING THE FOLLOW-UP PERIOD (25.6 MONTHS). IN 10 OF THE PATIENTS, NO NEUROLOGIC CHANGES WERE OBSERVED (5 WITH FRANKEL GRADE E, 5 WITH FRANKEL GRADE C). NEUROLOGIC IMPROVEMENT WAS SEEN IN 9 PATIENTS (8 WITH FRANKEL GRADE C AND 1 WITH FRANKEL GRADE B). NONE OF THE PATIENTS REPORTED WORSENING PAIN OR NEUROLOGIC SYMPTOMS AFTER SURGERY AND THERE WERE NO SURGERY-RELATED COMPLICATIONS SUCH AS NEURAL INJURY, CEREBROSPINAL FLUID LEAKAGE, CAGE DISLOCATION, SURGICAL SITE INFECTION, OR CARDIOPULMONARY COMPLICATIONS. THE MAIN POTENTIAL DRAWBACK OF USING A SMALL-DIAMETER CAGE IS THE RISK OF SHL RESULTING FROM SUBSIDENCE. THE REDUCED CAGE AREA MAY INCREASE THE AXIAL LOAD APPLIED TO THE CAGE; THEREFORE THE RISK OF SUBSIDENCE MAY BE GREATER THAN THAT WITH A LARGE CAGE. HOWEVER, INSERTING 2 CAGES SHOULD REDUCE THE RISK OF SUBSIDENCE BY DISTRIBUTING THE AXIAL LOAD EVENLY BETWEEN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970247 UNKNOWN HSB MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_ROD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention