MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H); DENTAL ABUTMENT SCREW

Model Number	ILPC343U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.First/given name: unknown / not provided.
Event or Problem Description
It was reported that the screw of the low profile abutment fractured.The fractured portion was removed from the implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certain® low profile one-piece abutment (ilpc343u) was returned for investigation.Visual evaluation of the as returned product identified fracture across the screw threads.Device history record (dhr) review for the lot (2020021298) 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 (2020021298) for similar events and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H)
• Common Device Name: DENTAL ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11391865
• Report Number: 0001038806-2021-00349
• Device Sequence Number: 1219921
• Product Code: NHA
• UDI-Device Identifier: 00844868021094
• UDI-Public: (01)00844868021094(17)250309(10)2020021298
• 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): 06/07/2021

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: 03/09/2025
• Device Model Number: ILPC343U
• Device Catalogue Number: ILPC343U
• Device Lot Number: 2020021298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR