MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB) OSSEOSPEED 3.5 S - 9 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 24611

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

Event Description

It was reported that a patient experienced a dental implant loss.

• Brand Name: OSSEOSPEED 3.5 S - 9 MM
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB); aminotegan 1; moindal, vastra gotalands lan [se-14] S431- 21; SW S431-21
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chausee 4; hanau, hessen 63457 ; GM 63457
• Manufacturer Contact: karl nittinger ; 221 west philadelphia street; suite 60w; york, PA 17404 ; 7178494424
• MDR Report Key: 11383043
• MDR Text Key: 233692181
• Report Number: 9612468-2020-00990
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091239
• 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: 02/22/2021

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 Catalogue Number: 24611
• Device Lot Number: 78202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention