MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V.

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); No Code Available (3191)

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.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 create the osteotomy for two dental implants (tooth position 7 and 10).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 implant in #7 was positioned correctly but the implant in #10 was positioned too distal.A second surgery is needed to correct the positioning of implant in #10.

Manufacturer Narrative

We have reviewed the matching of the plaster model onto the ct images carefully and we could confirm that the matching is optimal.We received notes indicating that the doctor had positioned the implant on position 10 in the middle of the edentulous space.We however noticed that this was not managed properly.As the implant position goes more distal as expected, it might be that there was a perception issue during the planning.Suggested to consider the use of a fully-guided implant safe guide to have a full sequenced drill and implant guidance.

• 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: 5958449
• MDR Text Key: 55002893
• Report Number: 3007362683-2016-00010
• 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,Followup
• Report Date: 08/19/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• 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
• Patient Outcome(s): Required Intervention