MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,6.0,13,MTX,MG; DENTAL IMPLANT

Model Number	TSVT6B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Initial reporter¿s first name is not provided / unknown.Additional 510(k) number is k101880.
Event or Problem Description
Doctor reports they were unable to achieve primary stability with the tsvt6b13 implant.Tooth site # 18.Site was grafted prior to placement.

• Brand Name: IMP,TSV,6.0,13,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10733549
• Report Number: 0002023141-2020-01777
• Device Sequence Number: 1667668
• Product Code: DZE
• UDI-Device Identifier: 00889024019898
• UDI-Public: (01)00889024019898(17)230921(10)1220485(241)TSVT6B13
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 09/21/2023
• Device Model Number: TSVT6B13
• Device Catalogue Number: TSVT6B13
• Device Lot Number: 1220485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 93