MAUDE Adverse Event Report: MATERIALISE NV PROPLAN CMF; PATIENT SPECIFIC GUIDE, MANDIBLE

Model Number	SD900.101
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Event or Problem Description
It was reported that guides did not fit.Approximately 3 weeks later revision surgery needed.
Additional Manufacturer Narrative
Investigation concluded that the devices met specifications and did not malfunction.The exact reason for the guide fitting issue cannot be confirmed, however the unfamiliarity of the surgeon with the respective devices was provided as a probable root cause by the sales representative.
Event or Problem Description
It was reported that guides did not fit.Approximately 3 weeks later revision surgery needed.

• Brand Name: PROPLAN CMF
• Common Device Name: PATIENT SPECIFIC GUIDE, MANDIBLE
• 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: 17235889
• Report Number: 3005718816-2023-00002
• Device Sequence Number: 5806934
• Product Code: JEY
• UDI-Device Identifier: 05420060351013
• UDI-Public: 05420060351013
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD900.101
• Device Catalogue Number: SD900.101
• Device Lot Number: MU23TARQOT
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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: 69 YR
• Patient Sex: Male