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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site # 6 removed due to stripped healing abutment.Dentist stripped hex of healing abutment.Could not remove screw on healing abutment after restorative doctor stripped the internal hex.I attempted to cut off the abutment but due to risk of damage to implant, opted to remove implant & replace.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) teeha355, tsv® bellatek® encode® emergence healing abutment 3.5mm(d) 5mm(p) xmm(h) for evaluation.Visual evaluation was performed, the abutment shows extensive damage.The drive feature was observed to be damaged as well.The dhr was requested, however an electronic copy is not available for review.The investigation will be reopened and updated upon any new or additional information provided to this complaint.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number 1267161 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 rev 20, the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The abutment shows extensive damage.Drive feature was observed to be damaged as well.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) teeha355, tsv® bellatek® encode® emergence healing abutment 3.5mm(d) 5mm(p) xmm(h) for evaluation.Visual evaluation was performed, the abutment shows extensive damage.The drive feature was observed to be damaged as well.Dhr review was completed for the subject lot number 1267161.No deviations or non-conformance's, 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: 1267161 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: function: 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 rev 20, the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The abutment shows extensive damage.Drive feature was observed to be damaged as well.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.

• 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: 18817940
• Report Number: 0001038806-2024-00352
• Device Sequence Number: 19961377
• Product Code: NHA
• UDI-Device Identifier: 00844868045762
• UDI-Public: (01)00844868045762(17)280424(10)1267161
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TEEHA355
• Device Lot Number: 1267161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 08/29/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic