MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS MDI 2.4X10MM MDI O-BALL PROSTHETIC HEAD - COLLARED; DENTAL IMPLANT

Catalog Number	MOB-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/23/2018
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 no obvious root cause of a material failure.
Event or Problem Description
On (b)(6) 2018 a dentist from (b)(6) reported that a (b)(6) -year-old female patient had a 3m¿ espe¿ 2.4x10mm mdi o-ball prosthetic head - collared (mob-10) implant fractured.On (b)(6) 2018 it was reported to 3m that the implant was surgically removed without complication using a lindemann burr.The current patient status was reported to be fine.The implant was placed in the upper jaw in (b)(6) 2013.The reason for implant breakage could not be determined.

• Brand Name: MDI 2.4X10MM 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: 7622024
• Report Number: 3005174370-2018-00006
• Device Sequence Number: 13903069
• Product Code: DZE
• UDI-Device Identifier: 30605861053915
• UDI-Public: 30605861053915
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: Dentist
• Device Catalogue Number: MOB-10
• Device Lot Number: N369640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/20/2018
• 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
• Patient Age: 77 YR