MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL,10M; DENTAL IMPLANT

Model Number	TMT4B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Indicated bone loss.The implant was removed.Tooth site # 14 (fdi).
Additional Manufacturer Narrative
Zimmer biomet complaint.(b)(6).Additional 510(k) numbers are k113753 and k112160.A summary investigation has been completed for bone loss 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 bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss 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.
Additional Manufacturer Narrative
This report is being submitted to report additional information.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.One problem associated with this minor defect rate is bone loss, which is likely attributed external factors including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Bone loss is a previously investigated failure which is currently trended on a monthly basis.Current implant design and manufacturing risk documentation assess bone loss 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 bone loss have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss 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.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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.As documented in the summary investigation, contributing factors for the reported event likely exist outside of zimmer biomet control, including those related to medical conditions / patient habits and surgical technique.Based on the summary investigation, no malfunction occurred upon investigation and no association between the dental implant and bone loss was found that can explain these events.Therefore, the reported event remains non-verifiable as it is a medical condition.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.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP TM 4.1MM MTX FULL,10M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13507926
• Report Number: 0002023141-2022-00307
• Device Sequence Number: 4063619
• Product Code: DZE
• UDI-Device Identifier: 00889024018938
• UDI-Public: (01)00889024018938(17)210131(10)63277892
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 01/31/2021
• Device Model Number: TMT4B10
• Device Catalogue Number: TMT4B10
• Device Lot Number: 63277892
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2016
• 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: 51 YR
• Patient Sex: Male