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

Model Number	FNT413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to bone loss.Patient also had inflammation.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One full osseotite® tapered implant 4 x 13mm (fnt413) was returned for investigation.Visual inspection of the reported product identified signs of use, bone residue around the implant and no apparent malfunction.A pre-existing condition noted on the per was high (type i) bone density.The reported device was located on tooth # 14 (fdi) and was implanted for approximately 8 months.The customer also reported inflammation, which will not be investigated, as it is a symptom of the reported bone loss event.The customer did not provide pictures or x-ray images of the reported bone loss.Advice history review was performed and no related nonconformances were noted.Also a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.The complaint reported bone loss.The product was returned.The reported fracture was confirmed via visual inspection.A definitive root cause for this complaint could not be determined.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® TAPERED IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9411476
• Report Number: 0001038806-2019-01511
• Device Sequence Number: 4130082
• Product Code: DZE
• UDI-Device Identifier: 00844868003342
• UDI-Public: (01)00844868003342(17)230727(10)2018071521(241)FNT413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Date: 07/27/2023
• Device Model Number: FNT413
• Device Catalogue Number: FNT413
• Device Lot Number: 2018071521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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
• Patient Weight: 70