MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI STANDARD O-BALL AND COLLAR 1.8MM X 13MM; DENTAL IMPLANT

Catalog Number OB-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 Type  Injury  

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.

Event Description

On august 5, 2015, a dental office reported that in (b)(6) 2011, a patient received two 3m espe mini dental implants at tooth locations #30 and #31 to stabilize two single fixed crowns.A torque wrench was used for placement, but a torque reading was not recorded and the patient's bone density was not measured.In (b)(6) 2015, one of the implants (mdi standard o-ball and collar 1.8mm x 13mm (ob-13)) fractured.The other implant placed in 2011 did not fracture and is still in the patient.The patient did not suffer an injury as a result of the fractured implant; however, the patient did have the implant piece removed by an oral surgeon, who used a trephine drill for surgical removal.

• Brand Name: MDI STANDARD O-BALL AND COLLAR 1.8MM X 13MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 5050507
• MDR Text Key: 24873597
• Report Number: 3005174370-2015-00058
• 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: Dentist
• Type of Report: Initial
• Report Date: 08/05/2015

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: No Information
• Device Catalogue Number: OB-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2015
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention