MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ LOCATOR¿ ABUTMENT 3.4MM(D) X 4MM(H)

Model Number	IMLOA004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment screw fractured at the site and had to be removed the implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Patient age not provided.Patient weight not provided.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
Condition of the returned product was evaluated to confirm the reported product experience.Evaluation: product experience report was received, reviewed, and evaluated by zest dental solutions in compliance with applicable fda and ous country regulations lhr review: applicable zest internal lot history records were reviewed to evaluate whether any internal deviations, non-conformances, and/or problems occurred during the manufacture of the lot, which could cause or contribute to the reported product experience condition.Data review: a review of other zest product experience files and related trending data for similar incidents was performed to evaluate whether other similar product experiences reports have been received and if data suggests any adverse trends may have contributed to the product experience root cause.Investigation results / root cause or most-likely root-cause: as part of each product experience investigation, zest performs an analysis to determine the root-cause of the reported problem.Depending upon the information provided, a true root-cause may or may not be determined.In these cases, the most-likely cause of the reported issue would be determined.Other known issues that are inherent to the business operations, typically ones that are related to shipping, handling, customer service, or other, are internally tracked and continually trended for unusual increases.As a result of the above investigation, zest has concluded the following as the root-cause or most likely root-cause of the reported product experience condition: it typically results from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.No manufacturing event was confirmed, event is tracked and trended with no further actions taken at this time.

• Brand Name: CERTAIN¿ LOCATOR¿ ABUTMENT 3.4MM(D) X 4MM(H)
• Common Device Name: 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: 15426423
• Report Number: 0001038806-2022-01424
• Device Sequence Number: 18020419
• Product Code: NHA
• UDI-Device Identifier: 00844868006343
• UDI-Public: (01)00844868006343(17)230822(10)1219558
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K012911
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 08/22/2023
• Device Model Number: IMLOA004
• Device Catalogue Number: IMLOA004
• Device Lot Number: 1219558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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 Sex: Female