MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Event Description

A journal article indicated a patient suffered a dislocated mandible on day three following surgery and required intermaxillary elastic fixation for a short time to allow for consolidation of the surgery and stabilization of the joint.The article states the dislocation was thought to be a result of the removal of the coronoid process which allowed the joint to become unstable.

Manufacturer Narrative

The user facility is foreign; therefore, a facility medwatch report will not be available.The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The lot history of the implanted unit is unknown; therefore, the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: TMJ
• Type of Device: TMJ
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 3671907
• MDR Text Key: 4339916
• Report Number: 0001032347-2014-00059
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR