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

Catalog Number	TEEHA355
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the emergence healing abutment does not detach from the implant, finding it impossible to do so.It was screwed in at 20 newtons.The affected dental position is #36.The procedure was completed using another abutment and another implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) teeha355, (tsv bellatek encode emergence healing abutment 3.5mm(d) 5mm(p) 5mm(h)) for evaluation.Visual evaluation was performed, there was signs of use.The abutment wouldn¿t disengage from the implant.Dhr review was completed for the subject lot number 1265629.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1265629 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque applied during placement/ seating exceeded recommended value.Therefore, based on the available information, a device malfunction did occur.The abutment wouldn¿t disengage from the implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19497969
• Report Number: 0001038806-2024-01198
• Device Sequence Number: 6661662
• Product Code: NHA
• UDI-Device Identifier: 00844868045762
• UDI-Public: (01)00844868045762(17)280314(10)1265629
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K212730
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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 Catalogue Number: TEEHA355
• Device Lot Number: 1265629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic