MAUDE Adverse Event Report: BIOMET 3I 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 Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Pma/510(k) number: k101880.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant on tooth site #30 was removed due to pain.Symptoms as a result of the event: swelling/edema.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the device catalog number was updated from tsvt6b8 to tsvt6b13.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.D1: brand name was updated.D4: catalog number was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.
Event or Problem Description
Upon follow up, the item number was updated.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4310.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads.No apparent malfunction was identified with the implant that would contribute to the reported event.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 1252445.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1252445 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are customer error ¿ improper techniques used during placement, or patient factors.Therefore, based on the available information, device malfunction did not occur.The reported event was non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMP,TSV,6.0,13,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16583166
• Report Number: 0001038806-2023-00558
• Device Sequence Number: 14639502
• Product Code: DZE
• UDI-Device Identifier: 00889024019898
• UDI-Public: (01)00889024019898(17)270216(10)1252445
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/27/2023

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: Other
• Device Model Number: TSVT6B13
• Device Catalogue Number: TSVT6B13
• Device Lot Number: 1252445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023; 03/02/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/03/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic