MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 13MM; DENTAL IMPLANT

Catalog Number	XIITP4313
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The dentist reported that the patient developed mycobacterium infection.It could be from sinus or lungs.Infectious disease doctor requested to remove implant.Sinus debridement procedure was done on (b)(6) 2016.
Additional Manufacturer Narrative
The complaint could not be verified as x-rays were not provided by the dentist.Returned implant was visually inspected.The device history record review was performed and did not identify any non-conformances.There were no manufacturing deviations identified which would cause or contribute to this complaint.A definitive root cause has not been determined.(b)(4).

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 6214159
• Report Number: 0001038806-2016-00370
• Device Sequence Number: 17777007
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: PK130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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 Date: 12/09/2020
• Device Catalogue Number: XIITP4313
• Device Lot Number: 2015112178
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR