MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI STANDARD O-BALL AND COLLAR 1.8 MM X 13 MM; DENTAL IMPLANT

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 Date 05/11/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, it was reported to 3m espe that one 3m espe mdi standard o-ball and collar 1.8 mm x 13 mm (ob-13) broke during implantation in position 33 and the apical fragment was removed using a dental burr.The additional surgery was performed without any complications.

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.The dentist stated that the implant broke during implantation and a turning force of 80 ncm was applied.According to the product instructions for use, forces of greater than 45 ncm should not be used when placing an implant.Exceeding the recommended force by such a large margin may have led to the breakage of the implant.

• Brand Name: MDI STANDARD O-BALL AND COLLAR 1.8 MM X 13 MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; st.aul MN
• Manufacturer Contact: 2510 conway avenue; st.paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4886330
• MDR Text Key: 6062199
• Report Number: 3005174370-2015-00037
• 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: 06/03/2015

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
• Device Lot Number: N623004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/01/2015
• 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
• Patient Age: 79 YR