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

Model Number	ILPC443U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
It was reported that abutment screw at tooth location 16 fracture.Another abutment was placed to finish procedure.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) certain® low profile one-piece abutment 4.1mm(d) x 3mm(h) (ilpc443u) was returned for investigation.Visual evaluation of the as returned product identified the abutment screw fractured.Device history record (dhr) review for the lot (2020111399) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2020111399) for similar events (complaint category keywords: fracture: screw) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)
• Common Device Name: DENTAL ONE-PIECE 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: 12112032
• Report Number: 0001038806-2021-01173
• Device Sequence Number: 3800909
• Product Code: NHA
• UDI-Device Identifier: 00844868021056
• UDI-Public: (01)00844868021056(17)251218(10)2020111399
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/12/2021

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: Lay User/Patient
• Device Expiration Date: 12/18/2025
• Device Model Number: ILPC443U
• Device Catalogue Number: ILPC443U
• Device Lot Number: 2020111399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• 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: 06/09/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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
• Patient Sex: Male