MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH INC.) ATLANTIS ABUTMENT GLODSHADED TI; ENDOSSEOUS DENTAL ABUTMENT

Catalog Number 35503S

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that when a dentist went to torque an s atlantis abutment goldshaded ti abutment, the implant (manufactured by nobel) began to turn and came out with the abutment stuck in it.Even outside of the patient's mouth the doctor was not able to remove the abutment from the implant.The surgeon tried to remove the abutment from the implant as well to no avail.

Manufacturer Narrative

Therefore, because this event resulted in a serious injury, it is reportable per 21 cfr part 803.A dhr review was completed as due diligence.The dhr review did not reveal anomalies.Materials were requested 3 times but were not returned.The root cause cannot be accurately determined without the aforementioned materials for analysis.

• Brand Name: ATLANTIS ABUTMENT GLODSHADED TI
• Type of Device: ENDOSSEOUS DENTAL ABUTMENT
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH INC.); north waltham MA
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4961224
• MDR Text Key: 6255989
• Report Number: 1222802-2015-00001
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093483
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 35503S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention