MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 3.7MM MTX,13MM; DENTAL IMPLANT

Model Number	TMMB13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant had to be removed due to becoming fractured.A new implant was placed after removal.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight not provided.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d4: expiration date and udi g3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h4: device manufacture date h6: evaluation codes h10: additional narrative one implant was returned for investigation.Visual evaluation of the as returned product identified that the implant was fractured at the body.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was low bone density (type iv).The reported device was located on tooth 33 (fdi) and was used for approximately 1 years, 11 month(s).X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: documents reviewed: instructions for use for tapered screw-vent®, advent® and trabecular metal¿ implants (ifu4869 rev 9-10/19) information identified: 'contraindications' 'warnings' & 'precautions' dhr review: dhr review was completed for the subject lot number 1230732.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number 1230732 for similar events and no other complaint was identified.Review completed utilizing keywords: 'dental : functional : fracture : implant' post market trend review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed as physical evaluation identified the fractured implant.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP TM 3.7MM MTX,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: 15130477
• Report Number: 0002023141-2022-01931
• Device Sequence Number: 20451529
• Product Code: DZE
• UDI-Device Identifier: 00889024018884
• UDI-Public: (01)00889024018884(17)240728(10)1230732
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2024
• Device Model Number: TMMB13
• Device Catalogue Number: TMMB13
• Device Lot Number: 1230732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male