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	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported infection.Patient returned with pain on the implant, secretion was observed.Pain and inflammation are reported as consequences of the infection.Tooth site # 13.
Additional Manufacturer Narrative
Zimmer biomet complaint cmp-(b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.Additional 510(k) numbers are k011028 and 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.

• 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: 13040053
• Report Number: 0002023141-2021-03670
• Device Sequence Number: 5409822
• 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: 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
• Report Date (Section B): 12/18/2021

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: 12/14/2021
• 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: 12/03/2021
• Initial Report FDA Received Date: 12/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 51 YR
• Patient Sex: Male