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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 13MM; DENTAL IMPLANT
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BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 13MM; DENTAL IMPLANT Back to Search Results
Model Number XIFNT513
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight: not provided.Initial reporter fax number: not provided.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
 
Event or Problem Description
It was reported that implant (xifnt513) was removed due to bone loss.After three months of implant placement, doctor noticed bone was crestally exposed.Implant was removed.Tooth location 5.Site was bone grafted.
 
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Brand Name
OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 13MM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key10268465
Report Number0001038806-2020-00981
Device Sequence Number2330258
Product Code DZE
UDI-Device Identifier00844868022022
UDI-Public(01)00844868022022(17)210329(10)2016031468(241)XIFNT513
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K130949
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 07/13/2020
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 Date03/29/2021
Device Model NumberXIFNT513
Device Catalogue NumberXIFNT513
Device Lot Number2016031468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/23/2020
Initial Report FDA Received Date07/13/2020
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;
Patient Age73 YR
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