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

Catalog Number MMC15

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Difficult To Position (1467)

Patient Problems Wound Dehiscence (1154); Edema (1820); Inflammation (1932); Skin Inflammation (2443)

Event Date 11/25/2016

Event Type  malfunction  

Event Description

The dentist reported that during of implant surgery, the implant was inserting correctly until the last 3 threads, in that moment the mount started spinning.The dentist was not able to introduce the implant nor to remove it, therefore there were placed bio oss and pericardium membrane in order to avoid implant exposure.Implant remains in patient's mouth.The dentist indicated that the mount is wear.Patient had inflammation, dehiscence and edema.

Manufacturer Narrative

Visual inspection of the as received product identified general signs of usage.The mount assembled onto a compatible implant with no difficulty during functional testing.The complaint was unconfirmed.The device functioned as intended.The lot number for the implant mount was not provided and therefore a device history record review could not be completed.A definitive root cause has not been determined.

Event Description

Upon visual inspection, the dentist does not believe that the implant hex is damage.

• Brand Name: IMPLANT MOUNT 3.4MM(D) X 15MM(L)
• Type of Device: IMPLANT 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: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6184849
• MDR Text Key: 63077956
• Report Number: 0001038806-2016-00354
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PEXEMPT
• 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: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: MMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 67 YR