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

Catalog Number 37503

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

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.Because the guide design was too fragile we redesigned the case according to our design parameters which causes the longer flanges to improve the guide strength.Based on the guide we received for complaint investigation we can conclude the clinician adjusted the flanges in order to have shorter flanges.Unfortunately we did not have any other option than making the flanges longer to avoid breakage of the guide.

Event Description

It was reported that a surgiguide did not properly fit in a patient's mouth.The dental implant placement surgery has been delayed.

• 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: 5799084
• MDR Text Key: 49754566
• Report Number: 3007362683-2016-00007
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/15/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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