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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I 3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 11.5MM; DENTAL IMPLANT
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BIOMET 3I 3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 11.5MM; DENTAL IMPLANT Back to Search Results
Model Number BOES411
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Inflammation (1932)
Date of Event 06/30/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age: not provided.Patient weight: not provided.Initial reporter 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 (boes411) was removed due to infection at tooth location 15.Inflammation was also noted.
 
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Brand Name
3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 11.5MM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key10468843
Report Number0001038806-2020-01240
Device Sequence Number3092145
Product Code DZE
UDI-Device Identifier00844868032458
UDI-Public(01)00844868032458(17)230516(10)2018050798(241)BOES411
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K133049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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 Date05/16/2023
Device Model NumberBOES411
Device Catalogue NumberBOES411
Device Lot Number2018050798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2020
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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