MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX,10MM; DENTAL IMPLANT

Model Number	TMM4B10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional pma/510(k) number ¿ k113753 | k112160.
Event or Problem Description
It was reported that the implant fractured in the patient's mouth.The implant was placed closed to the sinus and at this point in order to avoid perforation, the implant will stay in the patients mouth.They will call at a later dat if they decide to remove it.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed.No pre-existing conditions were noted on the product experience report (per).X-ray or picture was not provided.The reported device was location on tooth #13 and was used for approximately 3 years.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that the implant fractured in the patient's mouth.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP TM 4.1MM 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: 13385899
• Report Number: 0002023141-2022-00185
• Device Sequence Number: 4678183
• Product Code: DZE
• UDI-Device Identifier: 00889024018808
• UDI-Public: (01)00889024018808(17)211231(10)63541562
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: TMM4B10
• Device Catalogue Number: TMM4B10
• Device Lot Number: 63541562
• Was Device Available for Evaluation?: No
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2016
• 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
• Patient Sex: Unknown