MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 3.7, 10,MTX,MC,MG,HA; DENTAL IMPLANT

Model Number	TSVMH10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to the lip of the implant becoming fractured.Tooth #20.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Date of event not provided.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
Supplemental report provided as the customer was able to provide the event date and implant explant date.
Additional Manufacturer Narrative
One imp, tsv, 3.7, 10, mtx, mc, mg, ha (tsvmh10) was returned for investigation.Visual evaluation of the as returned product identified fracture around the collar.Additionally, there was bone tissue around the external threads functional testing could not be performed due to the nature of the device and event.Pre-existing conditions noted on the per were bruxism & low bone density ¿ type iii.The reported device had been placed on tooth # 20 for approximately 3 years.X-ray & picture evaluation: none provided.Review of appropriate documentation: documents reviewed: instructions for use tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Information identified: contraindications & precautions.Per the applicable ifu, patient factors such as severe bruxism, clenching, and overloading, may cause component fracture.Dhr review: dhr review for the lot (63802111) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (63802111) for similar events (complaint category keywords: functional: fracture: implant) and 1 other complaint was identified under (b)(4).Post market trending review: june post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.Sections updated: b4: date of this report.G3: date investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated.H4: device manufacturing date.H6: adverse event problem codes.H10: manufacturer's narrative.Section corrected: d4: expiration date.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: IMP, TSV, 3.7, 10,MTX,MC,MG,HA
• 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: 13803662
• Report Number: 0002023141-2022-00680
• Device Sequence Number: 19841151
• Product Code: DZE
• UDI-Device Identifier: 00889024344099
• UDI-Public: (01)00889024344099(17)221031(10)63802111
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K133339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: TSVMH10
• Device Catalogue Number: TSVMH10
• Device Lot Number: 63802111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 08/31/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 03/24/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2017
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG