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

Model Number	LPC441
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Expiration date unknown / not provided.
Event or Problem Description
Doctor reported that the abutment screw and the retaining screw fractured.Screws were placed on (b)(6) 2021.Procedure was finished using other low profile abutment.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One low profile abutment 4.1mm(d) x 1mm(h), was returned for investigation.Visual inspection via naked eye and camera magnification revealed abutment screw fractured at threads.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per form.Bone density is type iii.The reported devices were located on tooth site 36 (fdi) and length of use is 1 month.Device history record (dhr) review was completed for the subject lot numbee.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Moreover, a complaint history review of the subject lot number was performed for similar events using complaint category keywords: fracture screw.The complaint history review revealed that there are not existing non-conformances /capa/hhe//d/ie/product holds for the reported device related to the reported event.February post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture screw) and device.Based on the available information, device malfunction did occur and the reported event was confirmed following inspection and evaluation.

• Brand Name: LOW PROFILE 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12750284
• Report Number: 0001038806-2021-02109
• Device Sequence Number: 4498690
• Product Code: NHA
• UDI-Device Identifier: 00844868021322
• UDI-Public: (01)00844868021322(17)250717(10)2020070205
• 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): 04/11/2022

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: 07/17/2020
• Device Model Number: LPC441
• Device Catalogue Number: LPC441
• Device Lot Number: 2020070205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• 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 Age: 47 YR
• Patient Sex: Male