MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI 2.9 X 18 MM ONE PIECE IMPLANT TAPERED ABUT; IMPLANT, DENTAL, ENDOSSEOUS

Model Number MII-T18

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) 2015, 3m espe was informed that while placing a 3m(tm) espe(tm) mdi 2.9 x 18 mm one piece implant tapered abutment (mii-t18) with the 3m(tm) espe(tm) 13mm mdi ratchet adapter long (s7015), the implant fractured leaving a portion of the implant stuck in the ratchet adapter and the remaining portion in the patient's bone.The dentist is currently waiting on a larger trephine bur for removal of the implant piece.The dentist reported that the patient is fine and suffered no injury as a result of the fractured implant.At the time of the fracture, the implant was being placed into d1 bone; use of this product in d1 bone is not recommended per the product's instructions for use.

Manufacturer Narrative

At this time, neither the fractured implant pieces or the ratchet wrench have 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 use of the implant in non-indicated bone (too dense) may have been a contributing factor.Additionally, at the time of the fracture, the dentist was not using a torque-measuring wrench which would have enabled him to monitor any forces placed upon the implant.Since two devices were involved in this event, two manufacturer reports are being submitted.This manufacturer report (3005174370-2015-00017) is being submitted for the first device (mdi 2.9 x 18 mm one piece implant tapered abutment (mii-t18) and manufacturer report number 3005174370-2015-00018, is being submitted for the second device (13mm mdi ratchet adapter long (s7015)), respectively.

• Brand Name: MDI 2.9 X 18 MM ONE PIECE IMPLANT TAPERED ABUT
• Type of Device: IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4575297
• MDR Text Key: 5481232
• Report Number: 3005174370-2015-00017
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/05/2015

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: MII-T18
• Device Catalogue Number: MII-T18
• Device Lot Number: N531483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR