MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 2.9X13MM MDI ONE PIECE IMPLANT O-BALL ABUTMEN; DENTAL IMPLANT

Model Number MII-OB13

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 10/29/2014

Event Type  Injury  

Event Description

On (b)(6), 2014, it was reported to 3m espe that one 3m espe 2.9 x 13 mm mdi one piece implant o-ball abutment (mii-ob13) was broken and the apical fragments were removed by using a bone cutter and luxators.The additional surgery was performed on (b)(6) 2014.During the surgery the buccal bone lamella broke and parts of it had to be removed.The patient is now recovering.

Manufacturer Narrative

This incident appears to be related to incorrect pre-drilling.This deviation from the instructions for use may have led to enhanced turning forces which resulted in the breakage of the implants.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: 2.9X13MM MDI ONE PIECE IMPLANT O-BALL ABUTMEN
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS; 2111 mcgaw avenue; irvine CA 92614 000
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4339554
• MDR Text Key: 19969395
• Report Number: 3005174370-2014-00039
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081653
• 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: 11/20/2014

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: MII-OB13
• Device Catalogue Number: MII-OB13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/16/2014
• 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: 77 YR