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

Model Number	IMLOA003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locator abutment had become loose in the patient's mouth.Abutment was removed and replaced with a new one.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
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.Returned product evaluation: condition of the returned product was evaluated to confirm the reported product experience.Investigation results / root cause or most-likely root-cause: the reported product experience condition cannot be verified.No manufacturing event was confirmed, event is tracked and trended with no further actions taken at this time.The abutment met its configuration.A processing cap with an insert was placed over the abutment, and it retain its position as intended.No manufacturing defect was found.Sections updated: b4: date of this report d9: device availability and product return date g3: date investigation results were received g6: type of report and follow up number h2: follow up type h3: device evaluated h6: adverse event problem codes h10: manufacturer's narrative.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: CERTAIN® LOCATOR® ABUTMENT 3.4MM(D) X 3MM(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: 12908279
• Report Number: 0001038806-2021-02273
• Device Sequence Number: 17264329
• Product Code: DZE
• UDI-Device Identifier: 00844868006336
• UDI-Public: (01)00844868006336(17)260729(10)1247377
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 07/29/2026
• Device Model Number: IMLOA003
• Device Catalogue Number: IMLOA003
• Device Lot Number: 1247377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: 66 YR
• Patient Sex: Male