MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILPC442U
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
It was reported that while trying to place the low-profile abutment, the screw fractured.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).After additional information was received on apr 20, 2023 it was determined that this event no longer meets the criteria of a malfunction that if it were to recur would cause or contributed to a death and / or serious injury.As a result, the prior submission for mfr-0001038806-2023-00019 submitted on jan 3, 2023 is no longer considered a reportable event by the manufacturer and no further report will be submitted for this event.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16091101
• Report Number: 0001038806-2023-00019
• Device Sequence Number: 19335091
• Product Code: NHA
• UDI-Device Identifier: 00844868021063
• UDI-Public: (01)00844868021063(17)270124(10)2021120476
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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 Model Number: ILPC442U
• Device Catalogue Number: ILPC442U
• Device Lot Number: 2021120476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female