MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM TMJ & MODEL

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 03/02/2014

Event Type  Injury  

Event Description

Biomet denmark reports a tmj revision surgery due to poor bone quality and implant movement.

Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore, a facility medwatch report will not be available.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: CUSTOM TMJ & MODEL
• 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: 3607555
• MDR Text Key: 20695551
• Report Number: 0001032347-2014-00025
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2012
• Device Model Number: N/A
• Device Catalogue Number: CP-1394
• Device Lot Number: 485680
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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