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U.S. Department of Health and Human Services

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

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DENTSPLY IMPLANTS N.V. SURGIGUIDE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Catalog Number 37502
Device Problem Positioning Problem (3009)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  No Answer Provided  
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 customer used a surgiguide compatible with the astra tech implant system tx to place two implants in the mandible. The patient is partially edentulous and the guide was placed on the remaining teeth during surgery to perform the osteotomies and place the implants. The osteotomy for the first implant was not created at the desired position in the patient mouth as planned. The root of the neighboring tooth was damaged during surgery.

 
Manufacturer Narrative

Guide design and matching were correct; the diameter of the tube was also correct (4,70mm). Measurements in implant show there should be 1,44mm between the implant and the tooth root. Based on our investigation there is no guide design error; probably the components were not used correctly during surgery.

 
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Brand NameSURGIGUIDE
Type of DeviceSYSTEM, 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 Key5617743
MDR Text Key43985392
Report Number3007362683-2016-00003
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK113739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 03/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number37502
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/28/2016 Patient Sequence Number: 1
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