MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 2.1 X 13 MDI O-BALL PROSTHETIC HEAD - STANDARD

Model Number S1813IOB

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 - 2.1 x 13 mm standard thread (b)(4) was broken during implantation in position 41 and was removed by using a lindemann burr.The additional surgery was performed without any complications.The dentist stated that during the implantation a turning force of 60 ncm was needed; 3m espe instructions for use indicate not to exceed 45 ncm of force during placement.

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, which is consistent with what the dentist reported (reaching 60 ncm of force during placement).These excessive forces may be the result of insufficient pre drilling.

• Brand Name: 2.1 X 13 MDI O-BALL PROSTHETIC HEAD - STANDARD
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-0000 ; 6517331179
• MDR Report Key: 4401745
• MDR Text Key: 18033286
• Report Number: 3005174370-2015-00002
• 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: S1813IOB
• Device Catalogue Number: S1813IOB
• 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