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

Catalog Number	LPC441U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.D10: concomitant medical product: lpc442u, low profile one-piece abutment 4.1mm(d) x 2mm(h), lot: 2022091447.
Event or Problem Description
It was reported that 2 abutments fractured at the screw of the abutments at tooth sites 25-26, discovered at annual revision.Both abutments were removed.Proceeding was completed with another abutments.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) lpc441u, (low profile one-piece abutment 4.1mm(d) x 1mm(h)) for evaluation.Visual evaluation was performed, there was signs of use.The abutments screw was not fractured.The abutment had a fractured screw in its top end.Dhr review was completed for the subject lot number 2023020002.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2023020002 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.A retention screw was fractured inside the abutment top end.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20236631
• Report Number: 0001038806-2024-02063
• Device Sequence Number: 8089611
• Product Code: NHA
• UDI-Device Identifier: 00844868020950
• UDI-Public: (01)00844868020950(17)280206(10)2023020002
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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 Catalogue Number: LPC441U
• Device Lot Number: 2023020002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT ; DENTAL IMPLANT
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic