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

Catalog Number	TSVT6B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).G4: additional pma/510(k) number ¿ k101880.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
The patient reported that over the last few days swelling occurred between sites #14 and #15 and also have small amounts of puss.The patient is frustrated and hesitant to remove the implant.The clinician advised that the condition is not improving enough to keep the implant and recommended at least to explore and perform debridement.The patient was ok with that but once the implant was exposed, it was notably mobile and infected.Therefore the implant at tooth location #14 was removed and the patient will return in 3 months.Symptoms as a result of the event: abscess.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: explantation date was updated from (b)(6) 2023 to (b)(6) 2023, 'blood thinners' was move from b7.Other relevant history to d10.Concomitant medical products.The following sections are being reported: b4: date of this report was updated.B7.Other relevant history was corrected.D6b.Explantation date was corrected.D10.Concomitant medical products was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: even problem patient codes were added: 4577, 1750.H10: narrative/data was updated.H11: corrected data was updated.
Event or Problem Description
No additional 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): 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 ; 5619713230
• MDR Report Key: 17836546
• Report Number: 0002023141-2023-02658
• Device Sequence Number: 20773548
• Product Code: DZE
• UDI-Device Identifier: 00889024019898
• UDI-Public: (01)00889024019898(17)270425(10)1254312
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 03/26/2024

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 Catalogue Number: TSVT6B13
• Device Lot Number: 1254312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD THINNERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic