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

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 11/10/2014

Event Type  No Answer Provided  

Event Description

Pt received six 3m espe mdi 2.4 x 13 mdi o-ball prosthetic head - collared implants in the maxilla for denture stabilization on (b)(6) 2011; a soft reline was used and implants were not put into occlusion for 2 months (3m espe recommends 4-6 months).The office did not provide a bone density or torque measurement during placement.Pt was in dental office recently (exact date not provided to 3m espe) for a reline of the denture.On (b)(6) 2014 , the pt returned to the dental office to report that all of the implants felt tighter after the reline, except for the implant in tooth area number 11 which felt loose.Upon examination, the dentist reported the implant had fractured in the bone.Pt suffered no injury and dentist removed one of the broken pieces; however, the fractured implant left in the bone will be surgically removed by digging a trough around the implant site.

Manufacturer Narrative

The implant fragment was examined visually using a light microscope and was found to be within specification.The engineering analysis of the returned fractured implant showed evidence of a fracture induced by cantilever forces.The complaint history for this product does not show any pattern or trend in the number of fracture complaints.

• Brand Name: 2.4 X 13 MM MDI MAX WITH O-BALL HEAD AND COLLAR DENTAL IMPLANT DZE
• 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: 4356174
• MDR Text Key: 5198340
• Report Number: 3005174370-2014-00036
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2014

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: N286375
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR