MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H); DENTAL ABUTMENT

Model Number	ILPC341U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported temporary bridge 13-15 using an older 3i implant with a locator abutment have been removed.Screw-retained bridge with metal framework between 2 implants.Fracture of the conical abutment (the part of the abutment where the threads start) was discovered during removal of the temporary bridge and has been removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certain¿ low profile one-piece abutment 3.4mm(d) x 1mm(h) (ilpc341u) was returned for investigation.Visual evaluation of the as returned abutment identified that the abutment had signs of use.The abutment was fractured at the screw threads.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was bruxism.Bone density unknown.The reported device was located on tooth # 15 (universal) and was used for approximately for five (5) months.Dhr review was completed for the subject lot number 2022061156.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number 2022061156 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(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: 16245409
• Report Number: 0001038806-2023-00152
• Device Sequence Number: 12127129
• Product Code: NHA
• UDI-Device Identifier: 00844868021117
• UDI-Public: (01)00844868021117(17)270704(10)2022061156
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/10/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: ILPC341U
• Device Catalogue Number: ILPC341U
• Device Lot Number: 2022061156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male