MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 1.8 X 10 MDI O-BALL PROSTHETIC HEAD - COLLARED

Model Number OB-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 07/01/2013

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 standard - 1.8 x 10mm (ob-10) was broken and the apical fragments were removed by using a lindemann burr.The additional surgery was performed in (b)(6) 2013 without any complications.The surgery wound is completely healed and the patient is doing fine.The implant was inserted in (b)(6) 2011.Based on the information provided, the implant may have been fractured or weakened during implantation.

Manufacturer Narrative

The implant 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.Since the dentist is unable to provide details regarding patient's bone density, the forces used during placement and conditions of pre-drilling, it is possible that the implants were fractured or weakened.

• Brand Name: 1.8 X 10 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: 4337799
• MDR Text Key: 19971408
• Report Number: 3005174370-2014-00037
• 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: 11/14/2014

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-10
• Device Catalogue Number: OB-10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2014
• 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: 64 YR