MAUDE Adverse Event Report: DENTSPLY IMPLANTS MFG GMBH XIVE IMPLANT DRIVER; ENDOSSEOUS DENTAL IMPLANT ACCESSORY

Catalog Number 32266040

Device Problems Fracture (1260); Material Torqued (2980)

Patient Problem Failure of Implant (1924)

Event Date 12/10/2014

Event Type  Injury  

Event Description

In this event it was reported that a xive implant driver broke and the tip became stuck in a xive s plus dental implant.As a result, the implant had to be removed.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The implant loss event will be reported via asr.

• Brand Name: XIVE IMPLANT DRIVER
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ACCESSORY
• Manufacturer (Section D): DENTSPLY IMPLANTS MFG GMBH; mannheim ; GM
• Manufacturer Contact: helen lewis ; 221 w.philadelphia st., ste 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4961233
• MDR Text Key: 6190687
• Report Number: 9681851-2015-00007
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 12/10/2015

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: 32266040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention