MAUDE Adverse Event Report: BIOMET 3I TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H); DENTAL ABUTMENT

Model Number	TEHA3503
Medical Device Problem Code	Positioning Failure (1158)
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).Concomitant device: unknown biomet implant, lot# unknown /not available.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Location of device unknown at this time.
Event or Problem Description
Customer reported that the healing abutment did not seat in the implant.They were able to complete the procedure with another healing abutment.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111, 4114, 4110 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.H10: narrative/data was updated.The tsv¿ bellatek® encode® healing abutment 3.5mm (d) x 5.0mm (p) x 5mm (h) (teha3505) was not returned for investigation.Since product has not been returned, visual/functional inspection could not be performed.Functional testing to recreate the reported event could not be as the device was not returned.Patient pre-existing condition, tooth location and duration of implant are unknown due to limited information provided by customer.Dhr review was completed for the subject lot number 1242102.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 by lot number (1242102) was performed for similar events using keyword (does not seat) and no complaint about nonconforming products was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported events or product (teha3505).Therefore, based on the available information, device malfunction and the reported event could not be verified as the exact details of event were non-verifiable and the product was not returned.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H)
• Common Device Name: DENTAL ABUTMENT
• 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: 12295212
• Report Number: 0001038806-2021-01464
• Device Sequence Number: 3181574
• Product Code: NHA
• UDI-Device Identifier: 00844868040927
• UDI-Public: (01)00844868040927(17)260118(10)1242102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: TEHA3503
• Device Catalogue Number: TEHA3505
• Device Lot Number: 1242102
• 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: 07/19/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE
• Patient Sex: Unknown