MAUDE Adverse Event Report: MSD DEGGENDORF MFG ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	5030741
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part# 5030741 lot# 37lw visual and microscopic inspection revealed significant torsional/twisting deformation to the body of the implant.The threads that connect the spacer to the inserter have been stripped.It appears the threads were overloaded during the installation process.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 a healthcare professional via manufacturer representative regarding a cage used in acdf therapy for hernia.It was reported that the cage screw hole was broken.It was suspected that the cage was inserted in the wrong direction, and the cage was inserted into a place where it could not be inserted.The cage came loose from the inserter, and its screw hole got broken because the cage was inserted in that state.A new cage was opened and inserted by adding distraction between the vertebrae (there were no problems with the same inserter).It was reported that there was user error.No fragments of the implant seem to be left visibly in the patient.There was a delay of less than 60 mins.Patient symptoms are unknown.No further complications were reported/anticipated.

• Brand Name: ANATOMIC PEEK PTC CERVICAL FUSION 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: 21591514
• Report Number: 1030489-2025-01334
• Device Sequence Number: 8220033
• Product Code: ODP
• UDI-Device Identifier: 00643169357525
• UDI-Public: 00643169357525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 03/13/2025

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: 5030741
• Device Catalogue Number: 5030741
• Device Lot Number: 37LW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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