MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI STANDARD O-BALL AND COLLAR 1.8MM X 18MM; DENTAL IMPLANT

Catalog Number OB-18

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The reason for the breakage was a wrong choice of the implant type.Because the implant was too long it reached the corticalis and the higher bone density lead to the breakage of the implant during insertion.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.

Event Description

On (b)(6) 2015 it was reported to 3m espe that a 3m espe mdi mini dental implant o-ball prosthetic head - collared - 1.8 x 18mm, (ob-18) broke during implantation on position 34 and the apical fragment was removed in an additional surgery on the same day.The fragment was removed with a lindemann drill without any complications.

• Brand Name: MDI STANDARD O-BALL AND COLLAR 1.8MM X 18MM
• 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: 5265685
• MDR Text Key: 32657012
• Report Number: 3005174370-2015-00120
• 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: 11/04/2015

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: Dentist
• Device Catalogue Number: OB-18
• Device Lot Number: N540141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: 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: 56 YR