MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI 2.9X10MM MDI O-BALL PROSTHETIC HEAD - COLLARED; DENTAL IMPLANT

Catalog Number	MII-OB10
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant fragments were examined visually using a light microscope.The fractured surface was homogeneous and shows the typical picture of a fracture caused by excessive force.Highly probably the implant broke already during the implantation 14 years ago.This incident appears to be related to insufficient pre-drilling.It seems there is an underlying handling error.3m discontinued the sale of mdi implants in september 2016.
Event or Problem Description
On (b)(6) 2018, a dentist from (b)(6) reported that an (b)(6) male patient had a 3m¿ espe¿ 2.9x10mm mdi o-ball prosthetic head - collared (mii-ob10) implant fracture mii-ob10 implant removed after it was found broken on the tip 14 years after implantation in position 24.The fragment was removed via osteotomy without complication.

• Brand Name: MDI 2.9X10MM MDI O-BALL PROSTHETIC HEAD - COLLARED
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• MDR Report Key: 8293802
• Report Number: 3005174370-2019-00001
• Device Sequence Number: 1527480
• Product Code: DZE
• UDI-Device Identifier: 30605861053755
• UDI-Public: 30605861053755
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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
• Operator of Device: No Information
• Device Catalogue Number: MII-OB10
• Device Lot Number: F11574407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 82 YR