MAUDE Adverse Event Report: BIOMET 3I DO NOT USE-NANOTITE TM CERTAIN® PREVAIL® IMPLANT 4/5/4 X 15MM; DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report zimmer biomet complaint (b)(4).The reported device has been received for evaluation.Investigation has not yet begun.Once investigation has been completed, a follow up medwatch will be submitted.
Event or Problem Description
It was reported that the implant at tooth location 21 was removed due to bone loss and peri-implantitis.The site was grafted.The patient will return for a new implant after healing.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One nanotite tm certain® prevail® implant 4/5/4 x 15mm (niios4515) was returned for investigation with an unknown restoration.The investigation will exclude this restoration, as the event is stated to have occurred at the implant level.Visual inspection of the as returned product identified debris about the implant threads, and damage from removal at the collar.The product is too badly damaged from removal to accurately measure.The reported product was located on tooth # 21 and used for approximately 12 years.The customer has not provided additional pictures or x-ray images of the product.A device history review was performed and no related no deviations or 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.Sterilization record for the implant was reviewed and verified to have passed all sterilization activities with no issues or non-conformities identified.Complainant reported bone loss & peri implantitis.Bone loss and peri-implantitis of implant #21 with bone graft.The reported complaint could not be verified with the information provided, and following physical inspection of the returned product.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: DO NOT USE-NANOTITE TM CERTAIN® PREVAIL® IMPLANT 4/5/4 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9321717
• Report Number: 0001038806-2019-01377
• Device Sequence Number: 2388378
• Product Code: DZE
• UDI-Device Identifier: 00844868010807
• UDI-Public: (01)00844868010807(17)120403(10)658615(241)NIIOS4515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 04/03/2012
• Device Model Number: N/A
• Device Catalogue Number: NIIOS4515
• Device Lot Number: 658615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR