MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_HARDWARE

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

Patient Problem Nerve Damage (1979)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

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.D4: product <(>&<)> lot# unknown g3: ¿pma / 510(k) #: unknown b3: literature published date 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.

Event Description

Alexander o.Aguirre, mohamed a.R.Soliman, nicholas j.Minissale, patrick k.Jowdy, cathleen c.Kuo, asham khan, ryan m.Hess, david e.Smolar, barrett i.Woods, mark s.Eskander, paul j.Slosar, john pollina, jeffrey p.Mullin objective: interbody cages for spinal fusions are primarily constructed from polyetheretherketone or titanium compositions.However, these crude macroscopic materials pose limitations for improving the rates of bony fusions.The authors aimed to compare the fusion rates and postoperative complications in patients who underwent 2- level or 3-or 4-level anterior cervical discectomy and fusion (acdf) performed with the use of a novel biomimetic surface titanium cage.Methods: a retrospective multicenter study was conducted that included all patients who underwent multilevel acdf with this cage between january 2017 and april 2021.Patient demographics and procedure-related, radiographic, and postoperative complication data were collected.Results: a total of 124 patients were identified; 69 (55.6%) had a 3-or 4-level fusion and 55 (44.4%) had a 2- level fusion.The demographics of the 2 groups differed significantly only in terms of age (p [ 0.01).At 3 months, a significantly higher solid fusion rate was found for 2-level fusions than 3-or 4-level fusions (83.7% vs.56.3%, p [0.004); however, significance was lost at 6-months (98.2% vs.88.4%, respectively; p [ 0.08).No patients required posterior supplemental fixation.Transient dysphagia was the only postoperative complication that was significantly increased in the 3-or 4-level fusion group compared to the 2-level group (27.5% vs.9.1%, p [ 0.02).Reported events: the rate of postoperative dysphagia was significantly higher in the 3- or 4-level group than the 2-level group (27.5% vs.9.1%, p ¼ 0.02).There was no statistically significant difference found in the occurrence of other complications between the groups.Two (2.9%) infections were seen in the 3- or 4-level group; both were deep instrumentation infections that required surgical revision with instrumentation replacement and antibiotics; however, after surgical revision, both patients recovered with no additional complications.One (1.4%) other patient in the 3- or 4-level group had adjacent segment disease requiring an anterior extension of the fusion.One (1.8%) patient in the 2-level group required a second operation within 90 days from surgery to replace a migrated cage that caused cervical stenosis; after reoperation, this patient recovered with no additional complications.Conclusions: radiographic and clinical outcomes were equivalent in 3-or 4-level and 2-level acdfs in which these biomimetic surface titanium cages were used.Furthermore, the use of this technology led to high fusion rates with no requirement for posterior supplemental fusions.

• Brand Name: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 18950592
• MDR Text Key: 338253785
• Report Number: 1030489-2024-00195
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_HARDWARE
• Device Catalogue Number: MSB_UNK_HARDWARE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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
• Patient Outcome(s): Required Intervention