MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V.

Device Problem Structural Problem (2506)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in the need for 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.We discovered that the implant library had the surgical axis placement of the implant matched to the restorative/abutment axis, thereby misaligning the actual surgical placement axis.Until this issue has been rectified in our library we will block all orders with these specific angulated implants.We will correct this mistake in our next library release ((b)(6) 2016).

Event Description

A customer used a surgiguide to create the osteotomy for two keystone dental implants on tooth position #7 and #10.The central axis of the osteotomy for both implants did deviate 12 degrees to the buccal side from the original planning.The incorrect implant placement leads to the fact that the apical part of both implants are perforating the buccal plate and need grafting or the implants need to be removed and replaced during a second corrective surgery.

• 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: 5987398
• MDR Text Key: 55943608
• Report Number: 3007362683-2016-00011
• Device Sequence Number: 3
• Product Code: EBG
• 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: 08/30/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention