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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION 50 MM RIGHT STANDARD MANDIBLE; MANDIBLE IMPLANT

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BIOMET MICROFIXATION 50 MM RIGHT STANDARD MANDIBLE; MANDIBLE IMPLANT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091)
Event Date 12/26/2013
Event Type  Injury  
Event Description
A tmj revision surgery due to pain and swelling.
 
Manufacturer Narrative
The warnings in the package insert state this type of event can occur.The device is enrolled in the tmj clinical study and will be evaluated by the clinical research department.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.Device enrolled in tmj clinical study.
 
Manufacturer Narrative
The device was returned and analyzed as part of the (b)(6) study.This supplemental report is late information received from the (b)(6) study, which was reported as expected to the (b)(6) studies program, but inadvertently not recognized as 803 reportable until after the close of the study.According to the study: no failure mode was identified.Additionally, the patient had the biomet replacement device for over 8 years without indication of failure.She suffered a blunt facial trauma that led to a staged removal of the fossa first, and then the mandible component associated to a local neuroma formation.Evidence of dense fibrous tissue with focal ossification around the mandible component was verified by tissue biopsy.
 
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Brand Name
50 MM RIGHT STANDARD MANDIBLE
Type of Device
MANDIBLE IMPLANT
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key3698628
MDR Text Key20716811
Report Number0001032347-2014-00082
Device Sequence Number1
Product Code LZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP020016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional,study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/29/2014
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 Date12/01/2005
Device Model NumberN/A
Device Catalogue Number24-6550
Device Lot Number123481
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2014
Initial Date FDA Received03/25/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age44 YR
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