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

Model Number	5001222
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient undergoing posterior l umbar interbody fusion.For lower segment cesarean section (lscs).It was reported that although there were no problems with the capstone control ptc 6° 12×22 placed on the right side of l3/4 immediately after installation, a bone transplant was placed on the midl ine and a cage of the same size was placed on the left side.After that, the cage was dropped near the outer psoas.The physician determined that removal from the back was difficult, and that there was no adverse effect on tissue such as blood vessels, so the cage was left as is.On the right side of l3/4, capstone ptc 12×22 was placed and the procedure proceeded to screw insertion.There was delay of less than 60 mins.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: 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.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 CONTROL PTC¿ 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: 21855057
• Report Number: 1030489-2025-01754
• Device Sequence Number: 11933298
• Product Code: MAX
• UDI-Device Identifier: 00643169679764
• UDI-Public: 00643169679764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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 Expiration Date: 03/13/2026
• Device Model Number: 5001222
• Device Catalogue Number: 5001222
• Device Lot Number: H5410258
• 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: 03/25/2025
• Initial Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 03/13/2018
• 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