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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I; DENTAL IMPLANT DRIVER

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BIOMET 3I; DENTAL IMPLANT DRIVER Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.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 identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.
 
Event Description
Customer reported upon torqueing implant with hand wrench, implant internal hex gave with an apparent resulting in stripping.Tooth 19.
 
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Type of Device
DENTAL IMPLANT 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 Key18090804
MDR Text Key327587891
Report Number0001038806-2023-02122
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122300
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/07/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/08/2023
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 Age60 YR
Patient SexMale
Patient EthnicityNon Hispanic
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