MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 6 X 10MM; DENTAL IMPLANT

Catalog Number	INT610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Osteolysis (2377)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced allergic reaction and peri-implantitis at implant tooth site #14, with associated pain.The metal allergy let to inflammation and crestal bone loss.Therefore, the implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) int610, (osseotite® tapered certain® implant 6 x 10mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use.No apparent damage / malfunction was identified with the implant that would cause or contribute to the reported events.Measurements match drawing.Functional testing to recreate the reported events could not be performed due to the nature of the device & events.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2022091489.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022091489 for similar events and no other complaint was identified.Review completed utilizing keywords: allergic reaction & peri-implantitis the customer did not submit images for the reported events.Ifu review: documents reviewed: biomet 3i dental implant ifu p-iis086gi rev.J 2022/08.Information identified: warnings contraindications precautions.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are customer error and patient factors (material selection).Refer to attached summary investigation for peri-implantitis.Therefore, based on the available information, a device malfunction did not occur.The reported events were non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Peri-implantitis is an infectious disease that causes inflammation of the gum and the bone structure around a dental implant.Chronic inflammation causes bone loss, which can lead to implant failure thus its removal.Investigations performed for hundreds of events where either of these conditions, infection, or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss, and when right conditions prevail and led to peri-implantitis whether reported or not along with the other two, have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 6 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18966232
• Report Number: 0001038806-2024-00538
• Device Sequence Number: 7348459
• Product Code: DZE
• UDI-Device Identifier: 00844868006749
• UDI-Public: (01)00844868006749(17)271017(10)2022091489
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• 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): 08/26/2024

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 Catalogue Number: INT610
• Device Lot Number: 2022091489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2022
• 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: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic