MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILPC442U
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the low profile loosens, it loses its tightness.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One abutment was returned for investigation.Visual evaluation of the as returned product identified signs of use (wear) but no apparent signs of malfunction.Functional testing was performed with an in-house mating implant.The products engaged, retained and disengaged as normal.No pre-existing conditions were noted on the per.The device was intended for an unknown tooth site.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Per the applicable ifu, it is stated that improper technique and overloading can lead to device failure.Dhr review: dhr review for the lot (2020120162) 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: complaint history review was performed for the reported lot number (2020120162) for similar events (complaint category keywords: functional: loosening) and no other complaints were identified.Post market trending review: july post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event (e.G.Other product involved) were unknown.
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 2MM(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: 14432841
• Report Number: 0001038806-2022-00739
• Device Sequence Number: 12062776
• Product Code: NHA
• UDI-Device Identifier: 00844868021063
• UDI-Public: (01)00844868021063(17)260105(10)2020120162
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/05/2022

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: 01/05/2026
• Device Model Number: ILPC442U
• Device Catalogue Number: ILPC442U
• Device Lot Number: 2020120162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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: Female