MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 1.8 X 13 MDI O-BALL PROSTHETIC HEAD - COLLARED

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 Type  Injury  

Event Description

On (b)(6) 2014, it was reported to 3m espe that one 3m espe mdi mini dental implant o-ball prosthetic head - collared standard - 1.8 x 13 mm (ob-13) was broken during implantation in position 33 and the apical fragment was removed by using piezo surgery.The additional surgery was performed without any complications.

Manufacturer Narrative

The inplant fragments were examined visually using a light microscope.The fractured surface was homogenous, which indicates that fracture was torsional in nature, likely resulting from the application of too much force.The dentist stated that the conditions of pre-drilling were complicated because the bone structure of the pt's jaw was extremely dense.Additionally, the dentist didn't use a torque wrench with torque control.It is possible that the implant might have been fractured during implantation because of the conditions used for pre drilling and because a torque measuring wrench was not used.

• Brand Name: 1.8 X 13 MDI O-BALL PROSTHETIC HEAD - COLLARED
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-0000 ; 6517331179
• MDR Report Key: 4401730
• MDR Text Key: 5434326
• Report Number: 3005174370-2015-00001
• 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: 12/09/2014

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: OB-13
• Device Catalogue Number: OB-13
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/08/2015
• 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