MAUDE Adverse Event Report: MSD DEGGENDORF MFG CAPSTONE® SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	2991222
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Apnea (1720); Encephalopathy (1833); Neuropathy (1983); Pain (1994)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other: acute cystitis, hypoxic-ischemic encephalopathy, lumbar radiculopathy, severe obstructive sleep apnea.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 or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding an event which occurred post a clinical study (study id: (b)(4)) spinal fusion procedure in a patient (patient id: (b)(6)).It was reported that patient reports low back pain and rates it a 6-7 out of 10.Mild pain with range of motion.Pi states probability of mild disc strain and completed a steroid injection.Refilled diclofenac and flexeril for pain control.Prescribed physical therapy and if no improvements in 6-8 weeks, then will send for an mri.Patient also had acute cystitis, hypoxic-ischemic encephalopathy, lumbar radiculopathy, severe obstructive sleep apnea.No product malfunction reported.Sponsor assessment: not related to procedure, possible to tlif grafting material (autograft), body fusion device (capstone), and posterior supplemental fixation system.There were no further complications reported regarding the event.Ent.

• Brand Name: CAPSTONE® SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20492254
• Report Number: 1030489-2024-01334
• Device Sequence Number: 17187177
• Product Code: MAX
• UDI-Device Identifier: 00613994290960
• UDI-Public: 00613994290960
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: 2991222
• Device Catalogue Number: 2991222
• Device Lot Number: H5249715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 02/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic