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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR; ELEVATOR #301

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BIOMET MICROFIXATION ELEVATOR; ELEVATOR #301 Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The elevator was visually evaluated and the tip was found to be broken off.The broken section of the tip was returned.There were no indications of manufacturing defects.The most likely underlying cause of the complaint issue is excessive force applied by the user.Updated as a result of the device evaluation.
 
Manufacturer Narrative
The instrument was manufactured in 1997.The package insert for this product states "the tip of the instrument is extremely thin and delicate, care should be taken to avoid applying significant pressure to the tip.If excessive pressure is applied to the tip of the instrument, it will bend, rendering it useless.This elevator is not intended for use when removing a tooth that is not loose in the socket." there are no adverse effects reported as a result of this event, however, the device malfunction is subject to the two year rule.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.
 
Event Description
The customer reported that the elevator broke during the surgery in the patient's mouth.The broken portion was retrieved and did not cause any delay in the case or patient injury.
 
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Brand Name
ELEVATOR
Type of Device
ELEVATOR #301
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 Key4063593
MDR Text Key12197059
Report Number0001032347-2014-00291
Device Sequence Number1
Product Code EMJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 08/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number09-0257
Device Lot Number290610
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/11/2014
Initial Date FDA Received09/05/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/1997
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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