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

Model Number	SD900.102
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Knee and foot marker were positioned incorrectly on the fibula guide.
Event or Problem Description
It was reported that on fibula guide labels for knee/ankle were swapped.This was noticed immediately during surgery, there was no patient harm involved.
Additional Manufacturer Narrative
Section d4 - serial number has been deleted as it is not present in the label.Basic udi-di was deleted and primary udi-di was filled in instead.- udi related data quality updates only section g6- type of report changed from "initial" to "follow-up #:1".
Event or Problem Description
It was reported that on fibula guide labels for knee/ankle were swapped.This was noticed immediately during surgery, there was no patient harm involved.

• Brand Name: PROPLAN CMF
• Common Device Name: PATIENT SPECIFIC GUIDE, BONE GRAFT HARVESTING
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 18252470
• Report Number: 3003998208-2023-00023
• Device Sequence Number: 17813766
• Product Code: JEY
• UDI-Device Identifier: 05420060350016
• UDI-Public: 05420060350016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/02/2023

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: SD900.102
• Device Catalogue Number: SD900.102
• Device Lot Number: MU23DEXDUT
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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: 53 YR
• Patient Sex: Male