MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 2.9X13MM MDI ONE PIECE IMPLANT O-BALL ABUTMENT; DENTAL IMPLANT

Model Number MII-OB13

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/30/2014

Event Type  Injury  

Event Description

During placement of two 3m espe mdi one piece implant o-ball abutment 2.9 x 13mm for denture stabilization, the implants fractured and required surgical intervention to remove.The implants were being placed into tooth positions 21 and 23 in a patient with d2/d3 bone when they fractured at the o-ball region; at the time of fracture, a winged thumb wrench was being used for placement.The patient was referred to an oral surgeon who removed bone between the implants to remove them; bone grafting was performed.

Manufacturer Narrative

It was noted that the dental professional was not using an adjustable torque wrench at the time the fracture occurred.In the 3m espe instructions for use, it is recommended to use an adjustable torque wrench, so that forces on the implant do not exceed 45 n- cm.It is possible that the forces applied using the winged thumb wrench (as was used in this case) exceeded the recommended 45 n-cm.

• Brand Name: 2.9X13MM MDI ONE PIECE IMPLANT O-BALL ABUTMENT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4218762
• MDR Text Key: 21245134
• Report Number: 3005174370-2014-00030
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/02/2014

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: Health Professional
• Device Model Number: MII-OB13
• Device Catalogue Number: MII-OB13
• Device Lot Number: N593814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention