MAUDE Adverse Event Report: WARSAW ORTHOPEDICS UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_CAGE

Device Problem Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Summary: between (b)(6) 2017 and (b)(6) 2022, eligible patients were recruited for this trial.Participants were eligible for inclusion in the study if they were adults aged between 18 and 75 years.They must have demonstrated clinical symptoms of cervical radiculopathy or myelopathy stemming from subaxial cervical degenerative disc disease, whether due to soft disc herniation or spondylosis.Radiological validation of cervical disc degeneration, as evidenced by mri or ctscans, was imperative.All the candidates for the study had to have endured ineffective nonsurgical management of their cervical complications for at least 3 to 6 months.A cardinal prerequisite for all participants was the voluntary signing of a written informed consent form.Eligible candidates were evenly randomized into either the allograft cage (cornerstone-sr¿, medtronic) or bg cage (novomax; cgbio inc.) cohort.Surgery was performed by a single experienced spine neurosurgeon; the patient was positioned supine on a specialized flatbed jackson table and underwent general endotracheal intubation.In our practice, intraoperative neuromonitoring is employed.The patient¿s neck was gently extended using a folded sheet placed beneath the shoulders.To ensure sterility, the patient¿s neck region is prepped and draped, and an incision is made in alignment with the patient¿s natural skin crease.Using the smith-robinson approach under lateral fluoroscopy, the cervical vertebrae are accessed.The correct vertebral level is validated using fluoroscopy.The trachea and esophagus were retracted by retractors.Upon accessing the spine, comprehensive cervical discectomy is performed.Emphasis is placed on preserving the posterior longitudinal ligament first, especially during the crucial uncinectomy phase, ensuring dural sac protection.The border of the medial uncinate is meticulously discerned, and then the uncinate is methodically thinned using a high-speed diamond burr while safeguarding the sensitive nerve root beneath.Then, either the allograft or the bg cage (figure 1), an anterior cervical plate fortified with screws, is affixed to the adjoining vertebral bodies, ensuring cage fixation.Postoperatively, patients are provided with a cervical collar, and the immobilization is undertaken for a well-defined span of four weeks.Following their surgical procedures, patients were enrolled in a regular follow-up protocol.All participants underwent standardized pain management, physiotherapy, and meticulous wound care.Visits were scheduled for 1 month, 3 months, 6 months and 12 months postoperatively, and then on an annual basis thereafter.Subsidence and fusion status were evaluated at the 6- and 12-month follow-up visits.Out of the (b)(4) individuals assessed for eligibility, (b)(4) patients were excluded from the analysis due to their decline to participate in the randomization process, while the other two patients, although they agreed to the randomization process, were excluded because they were unlikely to comply with the follow-up protocol due to geographical distance and conflicting schedules.Finally, a total of(b)(4) participants consented to participate in the research and were incorporated in the analysis.Patients were randomly assigned to the treatment groups: allograft cage (n = 18; 24 levels) and bg cage (n = 22; 28 levels).No treatment crossover occurred.Patient-reported outcomes revealed significant improvements in both groups by the 12-month follow-up relative to their preoperative data.Data elucidates that the postoperative comparisons between the groups showed no noteworthy differences in vas scores for neck or arm pain or the neck disability index values.Upon postoperative assessment across various time points, both the allograft cage and bg cage consistently displayed no notable significant differences.The data suggest that both cage types provided commendable stability of the cervical spine post intervention.Reported events: regarding subsidence, allograft spacer recipients had a mean value of 1.90 ±.74 at 6 months that increased to 2.51 ±.90 at 12 months, a change that was statistically significant (p =.041).Subsidence increased significantly over time for both materials, yet the comparative difference between them remained statistically nonsignificant.In terms of fusion efficacy, at 6 months postoperatively , patients with allograft spacers showed a fusion rate of (b)(4), which increased to (b)(4) by the 12-month follow-up.A minority of patients experienced postoperative discomfort or localized pain at the incision or graft sites, none of these cases warranted subsequent reoperations due to serious complications, such as postoperative hematoma.(b)(4) patient in the allograft cohort who underwent c5-6 fusion was observed to have pseudoarthrosis and absorption of the allograft at the last follow-up and another patient who was implanted with an allograft at both the c5-6 and c6-7 levels and exhibited mild swallowing difficulties that persisted up to the latest followup.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: msb_unk_cage, serial/lot #: unknown, ubd: unknown, udi#: unknown; product id: msb_unk_cage, serial/lot #: unknown, ubd: unknown, udi# unknown: yanting liu, phd, chan woong park, md, phattareeya pholprajug, md, siravich suvithayasiri, md, jung hoon kim, md, chorong lee, msc, eun kim, msc, and jin-sung kim, md, phd.Efficacy of allograft versus bioactive glass-ceramic cage in anterior cervical discectomy and fusion: a randomized controlled study.Global spine journal 2023, vol.0(0) 1¿12 © the author(s) 2023.Doi: 10.1177/21925682231219225.D1, d4, g4: product identifiers are unknown e1: street 1 & street 2 address - department of neurosurgery, (b)(6) hospital, college of medicine h6: 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.H6: e2402 - pseudoarthrosis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18928147
• MDR Text Key: 339084880
• Report Number: 1030489-2024-00179
• Device Sequence Number: 1
• Product Code: MAX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CAGE
• Device Catalogue Number: MSB_UNK_CAGE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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 H11...."