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 Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).

Event Description

It was reported that during the surgery she was placing the implant with the mount mmc15 and it did not disengage from the implant.Doctor removed the implant and placed another implant instead with a 4 diameter.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one implant mount 3.4mm(d) x 15mm(l) (mmc15) and one osseotite® tapered implant 3.25 x 11.5mm (nt3211) were returned for investigation.Visual inspection of the as returned product identified signs of wear from use about the mount and implant threads.The two components are stuck together.The mount screw is rounded out and cannot be disengaged.Device history record (dhr) review could not be performed, as the lot numbers associated with the reported product are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the mmc15 and nt3211 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.

Event Description

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

• 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
• MDR Report Key: 11076243
• MDR Text Key: 223722017
• Report Number: 0001038806-2020-02117
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: MMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1