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

Model Number	2990826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (healthcare provider, distributor) regarding a patient implanted with spacer having transforaminal lumbar interbody fusion (tlif) therapy for l3-l4 herniated intervertebral disc and grade 2 spondylolisthesis.It was reported that after trialing, the surgeon fully inserted the cage.When attempting to impact the cage further into position, the surgeon noted that the cage holder had detached from the cage.The surgeon removed the implant and associated fragments completely.A new cage was then opened, implanted, and the procedure was completed uneventfully, no patient symptom were reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis #708669836, part # 2990826, lot# 63pu, a visual review of the returned implant identified that portions have been broken.Microscopic examination of the inserter interface identified damage to the threaded hole area and deformation on the top face, and fracture on one side around the inserter tang interface, consistent with significant impact and torsional loading.Microscopic examination of the fracture surface of the broken portions of the implant identified a fracture with rays emanating away from the area of crack initiation, consistent with overload.The observations are consistent with impaction overload.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: CAPSTONE® SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23592113
• Report Number: 3011795235-2025-00022
• Device Sequence Number: 10178930
• Product Code: MAX
• UDI-Device Identifier: 00613994291035
• UDI-Public: (01)00613994291035(17)311031(10)63PU
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2990826
• Device Catalogue Number: 2990826
• Device Lot Number: 63PU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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
• Patient Sex: Male