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

Model Number	4986045
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part#: 4986045, lot#: 90mj visual and microscopic examination identified the threads of the inserter interface to be stripped off, with evidence of deformation on the face of the implant or hole diameter.The nose of the implant as witness marks in the center.The above observations are consistent with significant impact during attempted assembly.This regulatory report is being submitted due to retrospective review through capa: 624392.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 healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for degenerative scoliosis.Levels implanted: l2/3 (successfully installed), l3/4 (successfully installed), l4/5 (successfully installed after addressing the issue) it was reported that the surgeon felt strange when inserting the olif cage, and when intravitreal insertion was stopped, the inserter's cage grasp was loose.The surgeon was asked to re-tighten the cage, but still felt it was loose, so it was replaced with a new one.It seems that no particular slack was felt when the cage was attached to the inserter.When the cage was inserted.Hammering was performed and insertion was attempted; however, it was difficult to get into the intervertebral space, so when it was checked outside the surgical field, he said that loosening was felt even after re-tightening the inserter.There was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: CLYDESDALE 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: 21557549
• Report Number: 1030489-2025-01263
• Device Sequence Number: 9262080
• Product Code: MAX
• UDI-Device Identifier: 00643169190733
• UDI-Public: 00643169190733
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: 4986045
• Device Catalogue Number: 4986045
• Device Lot Number: 90MJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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