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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 37506
Device Problems Device Slipped; Device Handling Problem
Event Type  Injury  
Manufacturer Narrative

Since this is a mucosa-supported guide, it is important that the prosthesis onto which it is based remain as stable as possible. The use of fixation screws for mucosa-supported guides is encouraged. 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.

 
Event Description

It was reported that while using a surgiguide to place six implants, the guide shifted during the drilling in the vestibular area (close to site 32 and 42) resulting in a fracture in the bone. The surgery was not completed. Also implant 36 does not seem to be placed in the planned area.

 
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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 Key5222774
Report Number3007362683-2015-00025
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial
Report Date 10/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number37506
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/07/2015
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: 11/13/2015 Patient Sequence Number: 1
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