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

Catalog Number 37503

Device Problem Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.Evaluation found there is scatter in the images and no clear outline of the mucosa information.There is nothing wrong with the fit on the plaster model or with the design in the planning file.

Event Description

It was reported that a surgiguide was used to create the osteotomy for three dental implants (tooth position 5, 6 and 7).After the first drilling step the surgical guide was removed to complete the additional drilling steps free handed according to the pilot guide drilling protocol.After placing the implants free handed, the customer discovered that the three implants were positioned too buccal.A second surgery is needed to correct the positioning of the implants.

• 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: 6003092
• MDR Text Key: 56590876
• Report Number: 3007362683-2016-00012
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/29/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• 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: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention