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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM; DENTAL IMPLANT
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BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM; DENTAL IMPLANT Back to Search Results
Model Number XIITP5415
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/09/2020
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 implant (xiitp5415) was removed due to infection at tooth location 5.Granulated tissue was reported during post-op check up.
 
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Brand Name
OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key9764829
Report Number0001038806-2020-00422
Device Sequence Number16768359
Product Code DZE
UDI-Device Identifier00844868022183
UDI-Public(01)00844868022183(17)230608(10)2018052471(241)XIITP5415
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K130949
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/27/2020
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 Date06/08/2023
Device Model NumberXIITP5415
Device Catalogue NumberXIITP5415
Device Lot Number2018052471
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2020
Initial Report FDA Received Date02/27/2020
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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