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

Model Number	ILPC443U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor reported the low profile abutment has been in mouth for 10 days and yesterday when doctor unscrewed it, everything came out and the abutment fell to the ground (a distance of about 40/50 cm) and the screw fractured.Tooth location not reported.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative one certain® low profile one-piece abutment (ilpc443u) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was conducted using applicable instructions for use, risk files and other available information.Device history record (dhr) review for the lot (2020071183) 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 lot (2020071183) for similar events and no other complaint was identified.Therefore, based on the available information and picture evaluation, device malfunction did occur and the reported event was confirmed.
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 3MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11036166
• Report Number: 0001038806-2020-02083
• Device Sequence Number: 1033710
• Product Code: NHA
• UDI-Device Identifier: 00844868021056
• UDI-Public: (01)00844868021056(17)250902(10)2020071183(241)ILPC443U
• 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: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: Lay User/Patient
• Device Expiration Date: 09/02/2025
• Device Model Number: ILPC443U
• Device Catalogue Number: ILPC443U
• Device Lot Number: 2020071183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention