MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 4X10MM MDI O-BALL PROSTHETIC HEAD - COLLARED

Model Number MOB-10

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 11/03/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, it was reported to em espe that one 3m espe mdi mini dental implant o-ball prosthetic head - collared max - 2.4 x 10mm (mob-10) was broken on position 13m and the apical fragments were removed by using a round burr.The additional surgery was performed in (b)(6) 2013 without any complications.The additional surgery was performed on (b)(6) /2014 without any complications.The implant was inserted on (b)(6) 2013.Based on the information provided, the implant may have been fractured or weakened during implantation.

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 homogenous and shows the typical picture of a fracture caused by excessive force.

• Brand Name: 4X10MM MDI O-BALL PROSTHETIC HEAD - COLLARED
• 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 55144-0000 ; 6517331179
• MDR Report Key: 4337790
• MDR Text Key: 21335737
• Report Number: 3005174370-2014-00035
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K031106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

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: MOB-10
• Device Catalogue Number: MOB-10
• Device Lot Number: N482693
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2014
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/08/2014
• 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: 65 YR