MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOCATOR ABUTMENT 4.1MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILOA002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the locator abutment broke at thread level inside implant body.Patient will return to replace abutment on a future undisclosed date.Tooth location # 13.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
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.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: no manufacturing defect was found.Most likely: 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.Known issue is being tracked and trended with no further actions taken at this time.The following sections have been updated: h3: changed "no" to "yes".
Additional Manufacturer Narrative
A duplicate submission was submitted under mdr supplemental report number 0001038806-2020-01691-1.A retraction was made for that submission.This submission is being sent to reflect any additional information that was on the duplicate submission.The following sections have been updated: b4: date of this report b5: describe event or problem d10: date returned to manufacturer g4: date received by manufacturer g7: checked "follow-up" h2: checked follow-up type h10: added manufacturer narrative.
Event or Problem Description
Update 01/13/2021 while attempting to locate product received at ca office, complaint was found to be duplicated.Information pulled for that complaint is as follows: it was reported that the locator abutment fractured at the threads in site 13 after 5 months in use.No injury to patient reported.Patient had good oral hygiene with no additional medical history reported.Patient will return to replace broken abutment.

• Brand Name: CERTAIN LOCATOR ABUTMENT 4.1MM(D) X 2MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10804569
• Report Number: 0001038806-2020-01769
• Device Sequence Number: 14182374
• Product Code: DZE
• UDI-Device Identifier: 00844868006077
• UDI-Public: (01)00844868006077(17)250201(10)1235755(241)ILOA002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2021

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: Lay User/Patient
• Device Expiration Date: 02/01/2025
• Device Model Number: ILOA002
• Device Catalogue Number: ILOA002
• Device Lot Number: 1235755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 01/13/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/16/2020; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR