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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L); DENTAL IMPLANT
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BIOMET 3I 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L); DENTAL IMPLANT Back to Search Results
Model Number BOES506
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 (nondesign/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.Zimmer biomet complaint (b)(4).
 
Event or Problem Description
It was reported that an implant (boes506) was removed due to infection at tooth location 13.
 
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Brand Name
3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L)
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key9461186
Report Number0001038806-2019-01614
Device Sequence Number3091484
Product Code DZE
UDI-Device Identifier00844868033646
UDI-Public(01)00844868033646(17)230418(10)2018040710(241)
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K150571
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/12/2019
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 Date04/18/2023
Device Model NumberBOES506
Device Catalogue NumberBOES506
Device Lot Number2018040710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2019
Initial Report FDA Received Date12/12/2019
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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