MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI MINI DENTAL IMPLANT O-BALL PROSTHETIC HEAD - 2.1 X 13 MM

Catalog Number S1813IOB

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 01/28/2016

Event Type  Injury  

Manufacturer Narrative

This incident appears to be related to a wrong choice of the implant type.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.The complaint history for this product does not show any pattern or trend in the number of fracture complaint.

Event Description

On (b)(6) 2016, 3m received a report that a 3m¿ espe¿ mdi mini dental implant o-ball prosthetic head - 2.1 x 13 mm, s1813iob was broken during an unsuccessful implantation on (b)(6) 2016.The apical fragment was removed without complication on the same day using a dental lindemann burr.Incorrect selection of implant type may be a contributor to this noted fracture, as it was too long and reached dense bone structures before proper placement.

• Brand Name: MDI MINI DENTAL IMPLANT O-BALL PROSTHETIC HEAD - 2.1 X 13 MM
• 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: 5951620
• MDR Text Key: 54748927
• Report Number: 3005174370-2016-00104
• 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: 08/17/2016

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: Dentist
• Device Catalogue Number: S1813IOB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR