MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 15MM; DENTAL IMPLANT

Model Number	XIFNT3215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	03/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the implant fell out of patient's mouth due to peri-implantitis.In late (b)(6) 2021 tooth #25 (universal) was extracted due to pain.Bone graft, membrane, prf, and implant was placed same day and the implant was torqued to 90 ncm.Pt then returned mid (b)(6) 2021 with complaint of pain when swallowing and notes were made that he had not been cleaning the healing cap.Cap was cleaned and antibiotics prescribed.In first part of (b)(6) 2021, pt came back to the office with complaint of soreness and stated the implant fell out a few days before.Two days later doctor diagnosed peri implantitis and debrided the site, placed doxycycline in the site for 5 mins then rinsed with saline and a peridex oral rinse.More bone graft, allograft, mixed with antibiotics was placed in the site and sutured closed.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: d9: device availability was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation was added: 3331 h10: narrative/data was updated.Dhr review was completed for the subject lot number.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.Lots were inspected and passed all acceptance criteria by qa.Sterilization records were reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot numbers for similar events and no other complaint was identified.As documented in the summary investigations, contributing factors for the reported event likely exist outside of zimmer biomet control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigations, no malfunction occurred upon investigation.The reported events remain non-verifiable as they are a medical condition.Osseointegrated dental implants are an important tool in prosthetic dentistry and provide edentulous patients with alternative replacements for teeth.Although most implants are extremely successful, with survival rates of up to 98% for implants placed in controlled clinical settings, implants can fail.Problems associated with this minor defect rate are infection, bone loss, and/or peri-implantitis, which are likely attributed external factors including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.These events are previously investigated failures which are currently trended on a monthly basis.Current implant design and manufacturing risk documentation assess infection, bone loss, and peri-implantitis as potential failures with adequate controls in place.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for these events have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect 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.With no signals indicating a systemic quality issue, no escalation to capa is required.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12062466
• Report Number: 0001038806-2021-01099
• Device Sequence Number: 3502633
• Product Code: DZE
• UDI-Device Identifier: 00844868021919
• UDI-Public: (01)00844868021919(17)250224(10)2020020254
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 02/24/2025
• Device Model Number: XIFNT3215
• Device Catalogue Number: XIFNT3215
• Device Lot Number: 2020020254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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: 77 YR