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

Model Number	LPC442U
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).
Event or Problem Description
It was reported that the low profile abutment was placed in mouth with torque 20ncm, and it was covered with a healing cap.When doctor wanted to upload the abutment with the crown he tried to unscrew the healing cap and the low profile abutment came also together with the healing cap (in block).The doctor replaced the abutment to continue with the procedure.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One low profile one-piece abutment 4.1mm(d) x 2mm(h) (lpc442u) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was conducted using the applicable instructions for use, risk files and other available information.Device history record (dhr) review for the lot (2020011807) 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 (2020011807) for similar events (complaint category keywords: functional: loosening) and no other complaint was identified.Therefore, based on the available information, device malfunction and the reported event could not be verified since the product was not returned.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 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
• MDR Report Key: 11574189
• Report Number: 0001038806-2021-00496
• Device Sequence Number: 19885278
• Product Code: NHA
• UDI-Device Identifier: 00844868020943
• UDI-Public: (01)00844868020943(17)250310(10)2020011807
• 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): 07/20/2021

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: Health Professional
• Device Expiration Date: 03/10/2025
• Device Model Number: LPC442U
• Device Catalogue Number: LPC442U
• Device Lot Number: 2020011807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1