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

Model Number	LPC442
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that he low profile abutment was placed in the implant and was uploaded with the crown.Patient came to the clinic some days later due to crown mobility.When doctor was trying to adjust the crown it was noticed that the crown was not the one loosen, it was the low profile abutment.The low profile abutment came out with the crown screwed.The abutment had been placed with 20 ncm torque.It was replaced with other abutment.
Additional Manufacturer Narrative
After additional information was received on may 26, 2021, it was determined that this event no longer meets the criteria of a malfunction that if it were to recur would cause or contributed to a death and / or serious injury.This is no longer considered a reportable event by the manufacturer and no further report will be submitted for this event.Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor has reported the screw that passed through the crown to the abutment (lpctsh) fractured and had to be removed.

• Brand Name: LOW PROFILE 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: 11574124
• Report Number: 0001038806-2021-00495
• Device Sequence Number: 4206260
• Product Code: NHA
• UDI-Device Identifier: 00844868021339
• UDI-Public: (01)00844868021339(17)250723(10)2020070259
• 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): 06/09/2021

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: 07/23/2025
• Device Model Number: LPC442
• Device Catalogue Number: LPC442
• Device Lot Number: 2020070259
• 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: 05/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1