MAUDE Adverse Event Report: MSD Deggendorf Mfg CAPSTONE PTC¿ Spinal System; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	3992609
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from the distibutor via a manufacturer representative regarding a device used for minimally invasive transf oraminal lumbar interbody fusion procedure.It was reported that during intra-op, the threaded connection spun freely without engaging or tightening, which prevented the cage from locking securely onto the insertion tool, and the original cage was set aside and qua rantined while a new implant was opened, which threaded and locked onto the inserter without issue.The procedure was completed successfully without patient injury.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
G2: country of origin: taiwan.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 PTC¿ 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 ; +1(763)526-5677
• MDR Report Key: 50850795
• Report Number: 3011795235-2026-00061
• Device Sequence Number: 9651824
• Product Code: MAX
• UDI-Device Identifier: 00643169187436
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 3992609
• Device Catalogue Number: 3992609
• Device Lot Number: 10TJ
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 10/08/2025
• 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: Unknown