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

Catalog Number 37504

Device Problem Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

Because 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 place four dental implants.Two of the implants were placed without issues.However, the implants planned in the areas of #20 and 21 were placed so far buccal that they lacked sufficient primary stability.A corrective surgery is now required.

Manufacturer Narrative

The device was not returned as indicated in the initial report.Multiple unsuccessful attempts were made to obtain the device for evaluation.

• 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: 5698678
• MDR Text Key: 46568345
• Report Number: 3007362683-2016-00004
• 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,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37504
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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
• Patient Outcome(s): Required Intervention