MAUDE Adverse Event Report: BIOMET 3I TSV¿ BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 6.5MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	TEEHA365
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the internal screw on healing abutment stripped.Extensive trouble retrieving healing collar which included rep on site; suspect that this compromised integration.Tooth #30.Had to drill away at healing abutment to retrieve; would not have been able to restore this implant.Took forever; had to reschedule patient to sedate her to get abutment off.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: first name unknown / not provided.
Additional Manufacturer Narrative
Zimvie received one (1) teeha365, (tsv bellatek encode emergence healing abutment 3.5mm(d) 6.5mm(p) 5mm(h) for evaluation.Visual evaluation was performed, the abutment was damaged at the drive feature region, likely due to the removal process.The encode abutment's bundle screw was not returned for evaluation.No malfunction was identified with the returned implant.Dhr review was completed for the subject lot number 1284983.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 1284983 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: damaged drive feature¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was the torque applied during placement/seating exceeded the recommended value.Therefore, based on the available information, a device malfunction did occur.The abutments drive feature was damaged.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.The following sections have been updated: b4: date of this report d9: device availability 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) 6.5MM(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: 21903986
• Report Number: 0001038806-2025-00880
• Device Sequence Number: 4085358
• Product Code: NHA
• UDI-Device Identifier: 00844868045793
• UDI-Public: (01)00844868045793(17)290818(10)1284983
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K212730
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Catalogue Number: TEEHA365
• Device Lot Number: 1284983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic