MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ABUTMENT 3.4MM(D) X 4MM(H); DENTAL ABUTMENT

Model Number	ILPC344
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).
Event or Problem Description
It was reported that the screw of abutment fractured.Abutment placed on (b)(6) 2022 and removed on (b)(6) 2021.Immediate loading.Bone density iii.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certainâ® low profile abutment 3.4mm(d) x 4mm(h) (ilpc344) was returned for investigation.Visual evaluation of the as returned abutment identified fractured screw at threads.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing condition noted on the per was low bone density ¿ type iii.The reported device had been placed on tooth #37.Device history record (dhr) review for the lot (2018051472) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2018051472) for similar events (complaint category keywords: fracture: screw) and no other complaint was identified.Therefore, based on the available information, device malfunction (fracture screw) 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 ABUTMENT 3.4MM(D) X 4MM(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: 15436331
• Report Number: 0001038806-2022-01454
• Device Sequence Number: 17541569
• Product Code: NHA
• UDI-Device Identifier: 00844868021193
• UDI-Public: (01)00844868021193(17)230717(10)2018051472
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 07/17/2023
• Device Model Number: ILPC344
• Device Catalogue Number: ILPC344
• Device Lot Number: 2018051472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2018
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG