MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) IMPLANT DRIVER; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Device Problems Positioning Failure (1158); Fracture (1260); Material Torqued (2980)

Patient Problem Failure of Implant (1924)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.A shaft fragment from a driver stuck in the handle, which is the reason, that no other handle can be fixed.The fragment is not at all in the position a shaft usually should be, when placed in the handle correct and as far up as described in the ifu.It was torn about 90° and hereby bent back the two clamping lashes inside the driver.

Event Description

In this event it was reported that an ev driver was stripped and would not engage.The session was not completed.

• Brand Name: IMPLANT DRIVER
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5157639
• MDR Text Key: 28556097
• Report Number: 9612468-2015-00022
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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