MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH DEMO IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

Investigation found that the returned implant was a demo implant used for hands-on training and thus not intended for clinical use in the human oral cavity.This reportable event was identified as "unusual" due to the use of the demo implant.Per asr exemption #(b)(4), events considered unusual, unique or uncommon are not reportable via asr and must be reported via an individual mdr submission.Therefore, this event is reportable per 21 cfr part 803.The returned implant is a demo implant, which is realizable on yellow color and differently treated surface.

Event Description

It was reported that a frialit synchro dental implant 3,8/11 which was placed on (b)(6) 2004 had lost osseointegration and was explanted on (b)(6) 2015.

• Brand Name: DEMO IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, baden-wurttemberg 68229 ; GM 68229
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, baden-wurttemberg 68229 ; GM 68229
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6031583
• MDR Text Key: 57550443
• Report Number: 9681851-2016-00030
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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: 09/16/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention