MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI MAX O-BALL HEAD & COLLAR 2.4MM X 13MM; DENTAL IMPLANT

Model Number MOB-13

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/30/2015

Event Type  Injury  

Event Description

In (b)(6) 2011, a female patient received two 3m espe mdi max w/o-ball head & collar 2.4mm x 13mm implants (mob-13), at tooth location #3, to stabilize a single fixed crown.On june 30, 2015, the dentist contacted 3m espe to report that both implants had fractured under the polished collar.Upon follow-up on july 2, 2015, the dental office reported the patient suffered no injury as a result of the fractured implants; however, the fractured implant pieces left in the bone will be surgically removed (the date for the removal of the implants has not been set).

Manufacturer Narrative

The implant fragments were not returned to 3m espe for analysis.The complaint history for this product does not show any pattern or trend in the number of fracture complaints.In this case, the implant used is not indicated for long-term fixation of single crowns, which may have been a contributing factor to its' fracture.

Manufacturer Narrative

The fractured implant was returned to 3m espe for evaluation.It appears that the implant fracture was due to cantilever loading.

• Brand Name: MDI MAX O-BALL HEAD & COLLAR 2.4MM X 13MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS; 2111 mcgaw ave.; irvine CA 92614
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-0000 ; 6517331179
• MDR Report Key: 4951554
• MDR Text Key: 20145446
• Report Number: 3005174370-2015-00045
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MOB-13
• Device Catalogue Number: MOB-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention