MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Catalog Number 37505

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/17/2016

Event Type  malfunction  

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.Evaluation found the reduction guide was "releaved" incorrectly at the bottom, near the end of the area to be reduced, resulting in the fracture.

Event Description

It was reported that a surgiguide broke while the doctor was trying to place guide, after reflecting the tissue.The surgery was aborted and a second surgery is needed.

• Brand Name: SURGIGUIDE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5504996
• MDR Text Key: 40531169
• Report Number: 3007362683-2016-00001
• Device Sequence Number: 1
• Product Code: LLZ
• 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: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• 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