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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I; DENTAL DRIVER

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BIOMET 3I; DENTAL DRIVER Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2023
Event Type  Injury  
Event Description
It was reported that during implant placementat tooth site 12, the implant disengaged from the driver and fell to the floor.Procedure was not completed.
 
Manufacturer Narrative
Zimvie complaint number (b)(4).Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.H3 other text : product not returned.
 
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Type of Device
DENTAL DRIVER
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
Manufacturer (Section G)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
Manufacturer Contact
susanne taylor
4555 riverside drive
palm beach gardens, FL 33410
5619713230
MDR Report Key18346665
MDR Text Key330736293
Report Number0001038806-2023-02467
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeSP
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/18/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexPrefer Not To Disclose
Patient EthnicityNon Hispanic
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