MAUDE Adverse Event Report: MATERIALISE USA LLC PROPLAN CMF; PATIENT SPECIFIC GUIDE, BONE GRAFT HARVESTING

Model Number	SD900.001
Medical Device Problem Codes	Positioning Problem (3009); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Knee and foot marker were positioned incorrectly on the fibula guide.
Event or Problem Description
Knee and foot markings on fibula guide were reversed.No injury or need for revision surgery.
Event or Problem Description
Knee and foot markings on fibula guide were reversed.No injury or need for revision surgery.
Additional Manufacturer Narrative
Section d4 - serial number has been deleted as it is not present in the label - udi related data quality updates only section g6 - type of report changed from "initial" to "follow-up #: 1".

• Brand Name: PROPLAN CMF
• Common Device Name: PATIENT SPECIFIC GUIDE, BONE GRAFT HARVESTING
• Manufacturer (Section D): MATERIALISE USA LLC; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA LLC; materialise usa llc; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 0032163966
• MDR Report Key: 18371009
• Report Number: 3005718816-2023-00005
• Device Sequence Number: 18092102
• Product Code: JEY
• UDI-Device Identifier: 05420060350016
• UDI-Public: 05420060350016
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: SD900.001
• Device Catalogue Number: SD900.001
• Device Lot Number: MU23RUKGEQ
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male