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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 Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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. We compared the build model with the plaster model. There is a deviation at the teeth 17 and 28 which probably causes the non fit in the patient mouth. The model in planning wasn't the same as situation in the patient's mouth.
 
Event Description
It was reported that a surgiguide did not fit in a patient's mouth. The dental implant placement surgery has been delayed.
 
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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 Key5710157
MDR Text Key47152701
Report Number3007362683-2016-00005
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K113739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 05/10/2016
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received06/09/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number37502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
Is This a Reprocessed and Reused Single-Use Device? No

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