MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 2.4X18MM MDI MAX WITH O-BALL HEAD; DENTAL IMPLANT

Model Number S1818MOB

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

On (b)(6) 2015, it was reported to 3m espe that a 3m(tm) espe (tm) mdi 2.4mm classic o-ball one-piece implant 18mm ((b)(4)), which had been placed on (b)(6) 2006, had fractured.A portion of the implant was attached in the patient's crown and the remaining portion of the implant was still in the patient's bone.No signs of trauma as a result of the fractured implant were reported.The dentist plans on removing the piece of the implant from the patient's bone by using a trephine drill.It should be noted that the implant used for this patient is not indicated for long-term fixation of single crowns.

Manufacturer Narrative

At this time, the fractured implant pieces have not been returned to 3m espe for analysis.The complaint history for fractures of this product was reviewed and is favorable.There have been no trends observed in the number of fracture reports.In this case, the implant used is not indicated for long-term fixation of single crowns, which may have been a contributing factor to its fracture.

• Brand Name: 2.4X18MM MDI MAX WITH O-BALL HEAD
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN 55144
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4620153
• MDR Text Key: 5700330
• Report Number: 3005174370-2015-00019
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2015

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: S1818MOB
• Device Catalogue Number: S1818MOB
• Device Lot Number: 3512051-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR