MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H); DENTAL ABUTMENT

Model Number	ILPC441U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.First/given name: unknown / not provided.
Event or Problem Description
It was reported that the abutment was fractured, the doctor confirms that the procedure was concluded with another tool and the patient did not suffer any impact on his health.The affected dental position is unknown.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).A certain® low profile one-piece abutment 4.1mm(d) x 1mm(h) (ilpc441u) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fracture at the threads.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Dhr review was completed for the subject lot number (2015100984).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.Complaint history review was performed for the reported lot number (2015100984) for similar event and nine other relevant complaints were identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.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 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: 12311715
• Report Number: 0001038806-2021-01492
• Device Sequence Number: 4137236
• Product Code: NHA
• UDI-Device Identifier: 00844868021070
• UDI-Public: (01)00844868021070(17)201102(10)2015100984
• 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): 12/08/2021

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 Expiration Date: 11/02/2020
• Device Model Number: ILPC441U
• Device Catalogue Number: ILPC441U
• Device Lot Number: 2015100984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• 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: 07/20/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2015
• 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 Sex: Unknown