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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 Problems Inadequacy of Device Shape and/or Size; Fitting Problem
Event Date 11/10/2015
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 surgiguide did not fit in a patient's mouth. The doctor stated that he opened a flap to try to obtain a better fit and drilled, but then perforated the lingual plate. The implant placement surgery was aborted and a second corrective surgery is needed.

 
Manufacturer Narrative

We checked the fit of the guide on the model: there was a minor instability in the fit of the guide on the model, caused by a human error during the manual finishing step. According customer's information that the guide didn't fit well, the guide was still used.

 
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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 Key5303606
Report Number3007362683-2015-00028
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 11/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2015
Is This An Adverse Event Report? No
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 Manufacturer11/16/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/29/2015
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: 12/16/2015 Patient Sequence Number: 1
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