MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V MINI SBM 3.3MM 3.5MM 13MM; DENTAL IMPLANT

Model Number	SVMB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Pain (1994)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated reports: 0002023141-2021-02457 and 0002023141-2021-02458.Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Initial reporter fax number unknown / not provided.Additional pma/510(k) number ¿ k011028|k013227.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
Doctor indicated infection.Patient presented with infection, pain and abscess.Patient not returning for future placement.Tooth sites #21-22-11.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated reports: 0002023141-2021-02457-1 and 0002023141-2021-02458-1.This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation code was added: 3331.Dhr review was completed for the subject lot number (1240770 & 63738353).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.Sterilization record (op160 & st3285) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (1240770 & 63738353) revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: infection).October post market trending was reviewed and there were no actionable events or corrective actions for the reported event (infection) or for the reported device (tsvb11 x 2 & svmb13).As documented in the summary investigation, 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 investigation, no malfunction occurred upon investigation.The reported event remains non-verifiable as it is a medical condition.

• Brand Name: IMPL SCR-V MINI SBM 3.3MM 3.5MM 13MM
• 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: 12425537
• Report Number: 0002023141-2021-02459
• Device Sequence Number: 3515597
• Product Code: DZE
• UDI-Device Identifier: 00889024018136
• UDI-Public: (01)00889024018136(17)220831(10)63738353
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K061410
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

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: 08/31/2022
• Device Model Number: SVMB13
• Device Catalogue Number: SVMB13
• Device Lot Number: 63738353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2017
• 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 Age: 76 YR
• Patient Sex: Female