MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	IFNT485
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
It was reported that the implant was removed due to becoming fractured.The site is currently healing.Tooth #46.
Additional Manufacturer Narrative
One (1) full osseotite® tapered certain® implant 4 x 8.5mm (ifnt485) was returned for investigation.Visual evaluation of the as returned product identified the implant with no fracture.No signs of malfunction.Product matched print specification where measured (caliper id: cal4063 due: jun 11, 2021) functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was high bone density (type i).The reported device was located on tooth # 46 (fdi) and was used for approximately 2 years and 16 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: per the applicable ifu, it is stated that breakage may occur following improper techniques used and when device is loaded beyond its functional capability.Dhr review: dhr review for the lot (2016120855) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot (2016120855) and no similar event or complaint was found.Review completed utilizing keywords: "fracture implant" post market trending review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported event (implant fracture) or product (ifnt485).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11527303
• Report Number: 0001038806-2021-00467
• Device Sequence Number: 14406665
• Product Code: DZE
• UDI-Device Identifier: 00844868005049
• UDI-Public: (01)00844868005049(17)220103(10)2016120855
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 01/03/2022
• Device Model Number: IFNT485
• Device Catalogue Number: IFNT485
• Device Lot Number: 2016120855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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: 26 YR