MAUDE Adverse Event Report: BIOMET 3I CERTAIN EP HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H); DENTAL ABUTMENT

Catalog Number	IWTH54
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the healing abutment would not fit/seat on the implant at tooth location #31.No additional information was provided.
Event or Problem Description
Additional information was received from the customer confirming that the reported device is manufactured by nobel, not zimvie.Based on this information, zimvie does not have reporting responsibility and this event and complaint will be voided.Therefore, this supplemental report is being submitted as a retraction for mfr number 0001038806-2025-00711 that was submitted on april 1, 2025.
Additional Manufacturer Narrative
This supplemental is being reported as a retraction statement as zimvie does not have reporting responsibility for the reported device and this event and complaint will be voided.Therefore, no additional reports will be submitted under mfr number 0001038806-2025-00711.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.H3 other text: device manufactured by a 3rd party.

• Brand Name: CERTAIN EP HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(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: 21739658
• Report Number: 0001038806-2025-00711
• Device Sequence Number: 20991515
• Product Code: NHA
• UDI-Device Identifier: 00844868009184
• UDI-Public: (01)00844868009184(17)260527(10)1245515
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• 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
• Report Date (Section B): 04/16/2025

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 Expiration Date: 05/26/2026
• Device Catalogue Number: IWTH54
• Device Lot Number: 1245515
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/09/2025
• 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: 04/01/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic