MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V SBM 3.7MM 3.5M M 10MM; DENTAL IMPLANT

Model Number	SVB10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Osteolysis (2377)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that the dental implant located in position #23 failed due to peri-implantitis.The dental surgical procedure was not completed with another implant.Symptoms as a result of the event: inflammation.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient age and date of birth unknown / not provided.Patient weight unknown / not provided.Additional pma/510(k) number ¿ k011028|k013227.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 non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: IMPL SCR-V SBM 3.7MM 3.5M M 10MM
• 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: 14876456
• Report Number: 0002023141-2022-01678
• Device Sequence Number: 14720879
• Product Code: DZE
• UDI-Device Identifier: 00889024018020
• UDI-Public: (01)00889024018020(17)220831(10)63736801
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: SVB10
• Device Catalogue Number: SVB10
• Device Lot Number: 63736801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2017
• 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 Sex: Male