MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 2.4 X 13 MDI O-BALL PROSTHETIC HEAD - COLLARED; DENTAL IMPLANT

Model Number MOB-13

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 07/14/2014

Event Type  Injury  

Event Description

It was reported to 3m espe that a 3m espe mdi mini dental implant o-ball prosthetic head - collared max - 2.4 x 13mm implant (mob-13) was broken and the distal fragment became loose approximately fifteen months after implantation on position 13.The apical fragment was removed by osteotomy on (b)(6) 2014.The add'l surgery was performed without any complications.The dentist stated that the patient is doing fine without any ongoing symptoms.

Manufacturer Narrative

This incident appears to be related to an insufficient number of implants placed.The instructions for use recommend placement of at least six implants for retention of full dentures in the maxillary.In this case, only five implants were set which could have resulted in overloading of force onto an implant resulting in the noted fracture.The implant fragments were examined visually using a light microscope.The fractured surface was homogeneous and shows the typical picture of a fracture caused by excessive force.

• Brand Name: 2.4 X 13 MDI O-BALL PROSTHETIC HEAD - COLLARED
• 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: 4106040
• MDR Text Key: 4702636
• Report Number: 3005174370-2014-00027
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031106
• 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: 08/19/2014

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: MOB-13
• Device Catalogue Number: MOB-13
• Device Lot Number: N436594
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR