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	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown/not provided.Age and date of birth unknown/not provided.Patient sex unknown/not provided.Weight unknown/not provided.Date of the event unknown/not provided.Product not returned.
Event or Problem Description
It was reported that the abutment fractured and was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The complaint report was received, reviewed, and evaluated by the manufacturer complaint process in compliance with applicable fda and ous country regulations.Applicable lot history records were reviewed to evaluate whether any internal deviations, non-conformances, or problems occurred during the manufacture of the lot, which could cause or contribute to the reported complaint condition.A review of other manufacturers complaint files and related trending data for similar incidents was performed to evaluate whether other similar complaints have been received and if data suggests any adverse trends may have contributed to the complaint root cause.Investigation results / root cause or most-likely root-cause: as part of each complaint investigation, the manufacturer 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 complaint condition: the reported complaint condition cannot be verified thread fracture during function.Most likely root cause of the failure mode / hazard : typically is the result from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.No findings are available since no physical evaluation was performed.
Event or Problem Description
No further event information is available at the time of this report.

• 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
• MDR Report Key: 10592223
• Report Number: 0001038806-2020-01455
• Device Sequence Number: 13741194
• Product Code: DZE
• UDI-Device Identifier: 00844868006343
• UDI-Public: (01)00844868006343(17)230824(10)1212372(241)IMLOA004
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K012911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 08/24/2023
• Device Model Number: IMLOA004
• Device Catalogue Number: IMLOA004
• Device Lot Number: 1212372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1