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

Model Number OB-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 04/24/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 it was reported to 3m espe that a 3m espe mdi standard o-ball and collar implant (ob-13) broke during implantation on (b)(6) 2015 and the apical fragment was removed the same day in an additional surgery.The apical fragment was removed using a dental round burr.The additional surgery was performed without any complications.

Manufacturer Narrative

This incident appears to be related to insufficient pre-drilling because the implant couldn't be inserted properly.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: MDI STANDARD O-BALL AND COLLAR 1.8MM X 13MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; st. paul MN
• Manufacturer Contact: 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4807994
• MDR Text Key: 5830604
• Report Number: 3005174370-2015-00034
• 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: 04/30/2015

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: Health Professional
• Device Model Number: OB-13
• Device Catalogue Number: OB-13
• Device Lot Number: N618245
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/29/2015
• 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: 64 YR