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

Model Number SD900.001

Device Problems Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

Knee and foot marker were positioned incorrectly on the fibula guide.

Event Description

Knee and foot markings on fibula guide were reversed.No injury or need for revision surgery.

• Brand Name: PROPLAN CMF
• Type of Device: 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
• MDR Text Key: 331058760
• Report Number: 3005718816-2023-00005
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060350016
• UDI-Public: 05420060350016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male