MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	XIFOSS410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implants on teeth sites #29 and #30 were removed due to pain.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-01712.Zimmerbiomet complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated report: 0002023141-2022-01712-1.This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: date returned to manufacturer was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were updated: 3331, 4109, 4111.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4310.H10: narrative/data was updated.One (1) osseotite certain 2 implant 5 x 10mm (xifoss510) and osseotite certain 2 implant 4 x 10mm (xifoss410) were returned for investigation.Visual evaluation of the as returned products identified that both implants had signs of use.No damage, wear, or signs of malfunction that would contribute to the event.Based on the evaluation, the device malfunction has not occurred.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimmer biomet.Dhr review was completed for the subject lot number 2021091275.It was confirmed that all operations and inspections were executed as per applicable procedure.Sterilization record op# 0210 was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number 2021091275 for similar events and no other complaint was identified.Dhr review was completed for the subject lot number 2021090367.It was confirmed that all operations and inspections were executed as per applicable procedure.Complaint history review was performed for the reported lot number 2021090367 for similar events and no other complaint was identified.The implant could not be functionally tested for the reported event (pain) as it is a medical condition.Therefore, the reported event couldn't be recreated.The complaint is not related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation is placement of implant in a patient with patient factors.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information was received at the time of this report.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 4 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15756570
• Report Number: 0001038806-2022-01713
• Device Sequence Number: 11992836
• Product Code: DZE
• UDI-Device Identifier: 00844868023142
• UDI-Public: (01)00844868023142(17)260924(10)2021090367
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: Health Professional
• Device Expiration Date: 09/24/2026
• Device Model Number: XIFOSS410
• Device Catalogue Number: XIFOSS410
• Device Lot Number: 2021090367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female