MAUDE Adverse Event Report: MATERIALISE NV PROPLAN CMF; PLATE, BONE

Model Number	SD900.051
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the internal documentation and the device showed that an older version of the patient specific plate was used to design the patient specific guide.Because of this, the holes pre-drilled with the guide did not match up with the holes of the plate used in surgery.Should additional information become available and an investigation result be available that changes this assessment, an amended medical device report will be filed.
Event or Problem Description
A patient specific guide was used to perform a mandible reconstruction.It was reported that the holes pre-drilled with the guide did not match up with the holes of the plate used in surgery.A delay of around 1 hour in surgery was reported.Surgeon reported that occlusion may be an issue, bone segments may not unite as well, implant direction not optimal, only two, instead of 4 implants were placed, more manipulation of the fibula segments that may compromise part of flap survival.Surgeon reported that another surgery will be required.

• Brand Name: PROPLAN CMF
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 7309143
• Report Number: 3003998208-2018-00002
• Device Sequence Number: 13765574
• Product Code: JEY
• UDI-Device Identifier: 05420060350511
• UDI-Public: 05420060350511
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2018

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: SD900.051
• Device Catalogue Number: SD900.051
• Device Lot Number: ME17FOXTOM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR