MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM 3.7MM MTX,10MM; DENTAL IMPLANT

Model Number	TMMB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported that an implant fracture at tooth site #32.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).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
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem 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' h6: evaluation codes h10: additional narrative one implant was returned for investigation.Visual evaluation of the as returned implant identified implant fractured at the collar region.Signs of use.Functional testing could not be performed since the product was fractured.Pre-existing conditions noted on the per were 'low bone density ¿ type iii'.The reported device had been placed on tooth 32 (fdi) for approximately 5 months.The patient is a smoker x-ray & picture evaluation: picture or x-ray evidence not 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, it is stated that improper techniques, severe bruxism, clenching, and overloading, may cause component fracture.Dhr review: dhr review for the lot (1232699) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.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 (1232699) for similar events (complaint category keywords: fracture: implant) and no other complaint was identified.Post market trending review: october 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.

• Brand Name: IMP,TM 3.7MM MTX,10MM
• 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: 14956168
• Report Number: 0002023141-2022-01755
• Device Sequence Number: 15191809
• Product Code: DZE
• UDI-Device Identifier: 00889024018860
• UDI-Public: (01)00889024018860(17)241013(10)1232699
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: Health Professional
• Device Expiration Date: 10/13/2024
• Device Model Number: TMMB10
• Device Catalogue Number: TMMB10
• Device Lot Number: 1232699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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: 58 YR
• Patient Sex: Female