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

Model Number	ILPC443U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that abutment fractured at the screw of the abutment.Tooth location 37.Abutment at 37 (ilpc442u) was successfully removed and implant remains in mouth.Abutment placed on (b)(6) 2019.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
It was reported that abutment fractured at the screw of the abutment.Tooth location 19.Lower portion of abutment at 19 (ilpc443u) could not be removed from the implant and implant had to be explanted.Abutment placed on (b)(6) 2019.
Additional Manufacturer Narrative
It was reported that abutment fractured at the screw of the abutment.Tooth location 36.Lower portion of abutment at 36 (ilpc443u) could not be removed from the implant and implant had to be explanted.Abutment placed on (b)(6) 2019.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certain® low profile one-piece abutment 4.1mm(d) x 2mm(h), ilpc442u, one certain® low profile one-piece abutment 4.1mm(d) x 3mm(h), ilpc443u and one osseotite® tapered certain® prevail® implant 5/4 x 10mm, xiitp5410 was returned for investigation.Both abutment were verified to be fractured at the screw thread and evidence of the remainder of the screw was identified within the returned implant.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Device history record (dhr) review was completed for the subject lot number (2016070732, 2020070532 & 2018080691).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.A lot specific complaint history review was conducted for the subject lot numbers (2016070732, 2020070532 & 2018080691) for similar events (complaint category keywords: fracture screw) and no existing non-conformances/capa/hhe/d/ie/product holds for the reported product was identified.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 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15073856
• Report Number: 0001038806-2022-01093
• Device Sequence Number: 5515590
• Product Code: NHA
• UDI-Device Identifier: 00844868021056
• UDI-Public: (01)00844868021056(17)250724(10)2020070532
• 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,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/24/2025
• Device Model Number: ILPC443U
• Device Catalogue Number: ILPC443U
• Device Lot Number: 2020070532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 12/12/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 07/21/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• 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 Age: 49 YR
• Patient Sex: Male