MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE CONTROL; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number MSB_UNK_CG_CPSTN P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.D.4, g.4.Product identifiers are unknown.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: ms b_unk_cg_cpstn p, serial/lot #: unknown, udi#: unknown.H.6.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.Byung-taek kwon, ho-joong kim, sanghoon lee, sang-min park, dae-woong ham, hyun-jin park, ohsang kwon, jin s.Yeom."feasibility and safety of a cao-sio2-p2o5-b2o3 bioactive glass ceramic spacer in posterior lumbar interbody fusion compared with polyetheretherketone cage: a prospective randomized controlled trial" acta neurochirurgica (2023) 165:135¿144.Doi: 10.1007/s00701-022-05429-x.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Byung-taek kwon, ho-joong kim, sanghoon lee, sang-min park, dae-woong ham, hyun-jin park, ohsang kwon, jin s.Yeom."feasibility and safety of a cao-sio2-p2o5-b2o3 bioactive glass ceramic spacer in posterior lumbar interbody fusion compared with polyetheretherketone cage: a prospective randomized controlled trial" acta neurochirurgica (2023) 165:135¿144.Doi: 10.1007/s00701-022-05429-x.Summary: 54 participants who required one- or two-level plif due to lumbar degenerative disorders were randomly assigned to receive a bgs-7 spacer or peek cage.Visual analog scale (vas), oswestry disability index (odi), european quality of life-5 dimensions (eq-5d), and pain detect score were evaluated before surgery and at 3, 6, and 12 months after surgery.The fusion rate, degree of osteolysis, cage migration, and subsidence around the cage (spacer) were evaluated on computer tomography (ct) images at 12 months after surgery.Reported events: 1.The subjects were patients aged 30¿80 years who required one- or two-level plif between l1 and s1.They were selected among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion, severe spinal stenosis, or spondylolisthesis.The bony landmarks of the spine were accurately exposed through a midline longitudinal incision.The pedicle screw was inserted using the conventional freehand technique.After screw insertion, laminectomy and flavectomy were performed to decompress the compressed nerve.Thereafter, discectomy and endplate preparation were performed followed by auto-local bone graft.Two bgs-7 spacers or peek cages were then inserted according to the assigned group.2.After surgery, two participants from each group were excluded because of implant removal surgery due to surgical site infection.3.For radiographic outcomes, osteolysis was 6 surgical levels (21.4%) in the peek cage group and 7 surgical levels (25%) in the bgs-7 spacer group, with no significant intergroup difference.4.The upper and lower endplate subsidence were 2.46 mm (±1.69) and 2.60 mm (±1.53) in the peek cage group.5.In total, 7 (25%) and 6 (23.1%) participants in the peek cage and bgs-7 groups, respectively, experienced more than one adverse reaction, with no significant differences between the two groups.6.Incidental durotomy occurred in 4 patients in the bgs-7 spacer group and in 5 patients in the peek cage group, but no clinical problem occurred.7.In the peek cage group, one pedicle fracture occurred after surgery and reoperation was performed.See attached literature article.

• Brand Name: CAPSTONE CONTROL
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17763905
• MDR Text Key: 323590853
• Report Number: 1030489-2023-00647
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CG_CPSTN P
• Device Catalogue Number: MSB_UNK_CG_CPSTN P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female