MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE

Catalog Number 37504

Device Problems Malposition of Device (2616); Device-Device Incompatibility (2919)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

In this event a dr reported that a surgiguide caused him to improperly place four implants.Two of the implants fenestrated the pt's bone and one implant was placed too buccal in the pt's mouth.All four implants still remain in the pt's mouth.It is unk if any further treatment is planned.

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 med or surgical intervention to preclude such.As such this event is reportable per 21 cfr part 803.The dr refused to return the device for eval.

• Brand Name: SURGIGUIDE GUIDE
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt limburg ; BE
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w; 221 w philadelphia st ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4841644
• MDR Text Key: 5869431
• Report Number: 3007362683-2015-00008
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113739
• 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: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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): Other