MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)

Model Number	ILPC444U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment screw fractured resulting in implant removal.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned abutment identified fracture at abutment screw threads.Complainant reported that the abutment screw fractured.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.The following sections have been updated: d4: expiration date, udi h3: device evaluated by manufacturer h6: evaluation codes h10: additional narrative.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)
• Common Device Name: 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: 15083975
• Report Number: 0001038806-2022-01119
• Device Sequence Number: 11736688
• Product Code: NHA
• UDI-Device Identifier: 00844868021049
• UDI-Public: (01)00844868021049(17)270228(10)2021100898
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 01/05/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ILPC444U
• Device Catalogue Number: ILPC444U
• Device Lot Number: 2021100898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose