MAUDE Adverse Event Report: BIOMET 3I IMPLANT MOUNT 3.4MM(D) X 15MM(L); DENTAL MOUNT

Catalog Number MMC15

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was impossible to separate the mount from the implant #34 and was removed.Procedure completed.

Manufacturer Narrative

Zimvie complaint number (b)(4).

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimvie complaint number (b)(4).Zimvie received one (1) mmc15, (implant mount 3.4mm(d) x 15mm(l)) for evaluation.Visual evaluation / functional test was performed, did not disengage/release during functional test.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the [mmc15] dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: dental : functional : does not disengage/release.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The mount did not disengage/release during functional test.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: IMPLANT MOUNT 3.4MM(D) X 15MM(L)
• Type of Device: DENTAL MOUNT
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19061131
• MDR Text Key: 339612337
• Report Number: 0001038806-2024-00692
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/27/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: MMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic