MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V.

Device Problems Fitting Problem (2183); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  No Answer Provided  

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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a surgiguide was used to place a dental implant.The implant transfer was too shallow and the guide did not fit.The clinician reported that additional steps during the surgery were needed to place the implant deeper.A second corrective surgery was not needed.

Manufacturer Narrative

The products have been returned and investigation shows that the product has been manufactured according to our standards.The fit on the model was good, the product has been finished correctly, the matching of the digital plaster model was good as well as the extractions performed on the stone model.

• 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: 5923696
• MDR Text Key: 54427088
• Report Number: 3007362683-2016-00009
• Device Sequence Number: 2
• Product Code: DZE
• 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,Followup
• Report Date: 08/05/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• 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