MAUDE Adverse Event Report: BIOMET 3I IMP TM 4.1MM MTX FULL, 11.5MM; DENTAL IMPLANT

Model Number	TMT4B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Pma/510k: k113753, k112160.
Event or Problem Description
It was reported that patient reported tenderness at #4 to his general dentist (b)(6) 2021.Pt.Was seen in our office on (b)(6) 2021.X-rays were taken and found the implant to be fractured.Implant was removed and site was bone grafted with 2 puros cancellous 0.5cc/1.2-30mm.Patient returning for replacement in 3-4 months.As a result of this event, no injury to the patient reported.Symptoms as a result of the event: tenderness.
Additional Manufacturer Narrative
An imp tm 4.1mm mtx full, 11.5mm (tmt4b11) was returned for investigation.Visual inspection of the as returned product identified worn marking due to usage, bone and a fracture at the middle threads.No pre-existing conditions were noted on the per.The reported device was location is #4 and was used for approximately 2 years.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63661610).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63661610) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: g6: checked "follow-up".H3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP TM 4.1MM MTX FULL, 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12829448
• Report Number: 0001038806-2021-02199
• Device Sequence Number: 6685419
• Product Code: DZE
• UDI-Device Identifier: 00889024018945
• UDI-Public: (01)00889024018945(17)220531(10)63661610
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• 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
• Report Date (Section B): 05/18/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: TMT4B11
• Device Catalogue Number: TMT4B11
• Device Lot Number: 63661610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2017
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male