MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H); DENTAL ABUTMENT

Catalog Number	ILPC443
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
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.D4: additional device information unknown / not provided.D10.Concomitant medical products ilpc444u, certain low profile one-piece abutment 4.1mm(d) x 4mm(h) lot 2020111397.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the dental abutments failed due to fractures at the screw level during placement on the implants.The doctor reports that the procedure was concluded by placing another abutments.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) ilpc443, (certain® low profile abutment 4.1mm(d) x 3mm(h)) for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use, and was observed fractured at the screw region.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 2018080251.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 2018080251 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is incorrect techniques used during placement/seating.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(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: 20999209
• Report Number: 0001038806-2024-02986
• Device Sequence Number: 9867594
• Product Code: NHA
• UDI-Device Identifier: 00844868021223
• UDI-Public: (01)00844868021223(17)231019(10)2018080251
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: Lay User/Patient
• Device Expiration Date: 10/19/2023
• Device Catalogue Number: ILPC443
• Device Lot Number: 2018080251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2024
• 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: 12/23/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2018
• 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