MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	FNT585
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Last name unknown / not provided.
Event or Problem Description
It was reported implant fractured and was removed.Symptoms as a result of the event: inflammation and pain.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One full osseotite® tapered implants 5 x 8.5mm (fnt585) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the product experience report.The reported product was located on tooth site 19 and used for approximately 5.5 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).The customer has not provided additional pictures or x-ray images of the product.Dhr review was completed for the subject lot numbers (2011051063).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2011051063 ) for similar event and no other complaint was identified.April post market trending was reviewed and there were no actionable events or corrective actions for the reported event (implant fracture) or product (fnt585).Therefore, based on the available information, device malfunction cannot be verified and the reported event is non-verifiable without return of the product and with the information provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).The two full osseotite® tapered implants 5 x 8.5mm (fnt585) were returned for inspection.Physical evaluation of the returned devices notes that both implants are fractured laterally across the threads.No pre-existing conditions were noted on the per.The reported product was located on tooth sites 36 & 37 (fdi) and used for approximately 5.5 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).The customer has not provided additional pictures or x-ray images of the product.Device history record (dhr) review was completed for the subject lot numbers (2011051063 + 2013100294).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2011051063 + 2013100294) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has occurred and the reported event is confirmed following evaluation of the returned product.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE TAPERED IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9877995
• Report Number: 0001038806-2020-00568
• Device Sequence Number: 561371
• Product Code: DZE
• UDI-Device Identifier: 00844868003410
• UDI-Public: (01)00844868003410(17)160523(10)2011051063(241)FNT585
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2016
• Device Model Number: FNT585
• Device Catalogue Number: FNT585
• Device Lot Number: 2011051063
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 08/04/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 06/09/2020; 08/27/2020
• 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: 69 YR
• Patient Weight: 73