MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM; DENTAL IMPLANT

Catalog Number	TSV6H11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.G4: pma/510(k) number: k013227.
Event or Problem Description
It was reported that the implant at tooth site # unknown was removed due to peri-implantitis.Patient had bone loss but implant was still solid.Debridement of implant and found cement debris on buccal aspect of implant.3-4 mm of bone loss.Placed puros and membrane at time of debridement.At 3 month check after debridement, patient had pus and bone loss was still present.Implant was removed.Symptoms as a result of the event: infection.
Event or Problem Description
It was reported that the patient had bone loss but implant was still solid.Debridement of implant and found cement debris on buccal aspect of implant.3-4 mm of bone loss.Placed puros and membrane at time of debridement.Symptoms as a result of the event: infection.
Additional Manufacturer Narrative
This report is being submitted to report additional and corrected information to 0002023141-2024-02004.The correction is that the implant was not removed at this point.There was medical/surgical intervention performed though.The site was debrided, grafted and membrane was placed.The following sections are being reported: b5.Describe event or problem: d6b.If explanted, give date.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: impact code(s).H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.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.H3 other text : summary investigation.

• Brand Name: IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19553754
• Report Number: 0002023141-2024-02004
• Device Sequence Number: 6715902
• Product Code: DZE
• UDI-Device Identifier: 00889024019461
• UDI-Public: (01)00889024019461(17)241020(10)1228372
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/17/2024

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: Lay User/Patient
• Device Expiration Date: 10/19/2024
• Device Catalogue Number: TSV6H11
• Device Lot Number: 1228372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2019
• 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: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic