MAUDE Adverse Event Report: BIOMET 3I TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 7MM(H); DENTAL ABUTMENT

Catalog Number	TEEHA357
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.D10.Concomitant medical products teeha357, tsv bellatek encode emergence healing abutment 3.5mm(d) 5mm(p) 7mm(h) lot 1270646.
Event or Problem Description
It was reported the doctor tried to place abutments and screw wouldn't engage.Doctor assumed it was the implant.Implant was removed and new one was placed.New abutment was also placed.Unknown tooth number.
Additional Manufacturer Narrative
Zimvie received one (1) teeha357, (tsv bellatek encode emergence healing abutment 3.5mm(d) 5mm(p) 7mm(h)) for evaluation.A visual evaluation and a functional test were performed, the abutment has minor signs of wear/use.The abutment was tested with in-house implant, and it engages and disengages as intended.Dhr review was completed for the subject lot number 1267948.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 1267948 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: does not assemble.¿ the customer did submit an image of the reported event.The image was of the patient tongue with a sore.A definitive root cause could not be determined since a device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The abutment engaged and disengaged with an in-house implant as intended.The reported abutment assembling event was unconfirmed.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.The following sections have been updated: b4: date of this report, g3: date received by manufacturer, g6: checked "follow-up," h2: checked follow-up type, h3: changed "no" to "yes," h6: entered evaluation codes, h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 7MM(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: 21395094
• Report Number: 0001038806-2025-00352
• Device Sequence Number: 8274157
• Product Code: NHA
• UDI-Device Identifier: 00844868045779
• UDI-Public: (01)00844868045779(17)280513(10)1267948
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Catalogue Number: TEEHA357
• Device Lot Number: 1267948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• 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: 02/18/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 ABUTMENT SEE H10 NARRATIVE; DENTAL ABUTMENT SEE H10 NARRATIVE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic