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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM; DENTAL IMPLANT
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BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM; DENTAL IMPLANT Back to Search Results
Model Number INT3210
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age: not provided.Patient weight: not provided.Initial reporter name, email address, fax number: not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
 
Event or Problem Description
It was reported that implant (int3210) was removed due to infection.
 
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Brand Name
OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key10468517
Report Number0001038806-2020-01235
Device Sequence Number2552917
Product Code DZE
UDI-Device Identifier00844868006596
UDI-Public(01)00844868006596(17)240118(10)2019010531(241)INT3210
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K063341
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/28/2020
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
Operator of Device Lay User/Patient
Device Expiration Date01/18/2024
Device Model NumberINT3210
Device Catalogue NumberINT3210
Device Lot Number2019010531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/06/2020
Initial Report FDA Received Date08/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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