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

Model Number SD900.051

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 01/31/2018

Event Type  Injury  

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 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
• Type of Device: PLATE, BONE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 7342597017
• MDR Report Key: 7309143
• MDR Text Key: 101372528
• Report Number: 3003998208-2018-00002
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060350511
• UDI-Public: 05420060350511
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD900.051
• Device Catalogue Number: SD900.051
• Device Lot Number: ME17FOXTOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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): Required Intervention
• Patient Age: 54 YR