MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOCATOR ABUTMENT 3.4MM(D) X 6MM(H); DENTAL LOCATOR ABUTMENT

Model Number	IMLOA006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight: unknown / not provided.Address and fax number: unknown / not provided.
Event or Problem Description
Doctor indicated fracture.The screw of imloa006 broke even though it was only a short time after it started to be used.The doctor's complaint that the strength may be weak.The fractured portion was removed and a new imloa006 was placed.There is no health hazard.Excessive load.Tooth site #12.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
The complaint report was received, reviewed, and evaluated by the zest dental solutions complaint process in compliance with applicable fda and ous country regulations.Applicable zest internal 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 zest 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.Condition of the returned complaint related product was evaluated to confirm the reported product complaint.As part of each complaint 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.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: no manufacturing defect was found.Hazard experience: thread fracture during function.Most likely root cause of the failure mode / hazard: thread fracture during function typically results from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.Known issue is being tracked and trended with no further actions taken at this time.

• Brand Name: CERTAIN LOCATOR ABUTMENT 3.4MM(D) X 6MM(H)
• Common Device Name: DENTAL LOCATOR ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11789458
• Report Number: 0001038806-2021-00762
• Device Sequence Number: 19820675
• Product Code: DZE
• UDI-Device Identifier: 00844868006367
• UDI-Public: (01)00844868006367(17)250608(10)1237564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 06/08/2025
• Device Model Number: IMLOA006
• Device Catalogue Number: IMLOA006
• Device Lot Number: 1237564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR