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

Model Number	2990932
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresthesia (4421); Unspecified Nervous System Problem (4426)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 2990932, serial/lot #: (b)(6), ubd: 06-may-2023, udi#: (b)(4).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 clinical study, healthcare provider via manufacturer representative regarding a patient with clinical study id (b)(6).It was reported that, patient had abnormal sensory function (l5 right light touch and pin prick).Previous sensory function was noted as normal and was now noted as abnormal for l5 right light touch and pin prick.Procedure/technique performed was transforaminal lumbar interbody fusion open surgical access.Levels implanted were l4-l5 and l5-s1.Site related assessment: adverse event was not related to capstone peek spinal system implant, posterior supplemental fixation system, transforaminal lumbar interbody fusion grafting material and to procedure.Sponsor assessment (oc muo): cec adjudicated as possible related to tlif procedure, tlif grafting material, body fusion device, and supplemental fixation system.Site seriousness assessment: severity of adverse event was mild.Outcome of adverse event was recovering/resolving.The onset date was (b)(6) 2024.There were no further complications reported regarding the event.

• 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: 20911628
• Report Number: 1030489-2024-01672
• Device Sequence Number: 20948841
• Product Code: MAX
• UDI-Device Identifier: 00613994387165
• UDI-Public: 00613994387165
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: 08/27/2021
• Device Model Number: 2990932
• Device Catalogue Number: 2990932
• Device Lot Number: H13T1464
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/12/2024
• Date Device Manufactured: 08/27/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male