MAUDE Adverse Event Report: BIOMET 3I; DENTAL MOUNT

Device Problem Mechanical Problem (1384)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the mount rotates on the hexagon of the implant and prevents lowering it to the desired level.Implant bost 3,25 wide works perfectly fine with the mount.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).D10.Concomitant medical products nt3213, osseotite tapered implant 3.25 x 13mm lot 2022051312.Since the lot number and device will not be returned , identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.H3 other text : product not returned.

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410
• MDR Report Key: 18063790
• MDR Text Key: 327241073
• Report Number: 0001038806-2023-02093
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/02/2023

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic