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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE

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DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE Back to Search Results
Catalog Number 37502
Device Problems Break; Positioning Failure
Event Type  Injury  
Manufacturer Narrative

Because surgery could not be completed, this event is reportable per 21 cfr part 803. We checked the design and found no points of particular concern. The fracture probably was caused by a combination of a particularly large opening due to the neighboring tooth and an excessive force applied during surgery.

 
Event Description

A dentist reported the fracture of a surgiguide during surgery. The surgiguide was being used to support the placement of two implants in the mandible.

 
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Brand NameSURGIGUIDE GUIDE
Type of DeviceVARIOUS, EBG, LLZ, DZE
Manufacturer (Section D)
DENTSPLY IMPLANTS N.V.
hasselt limburg
BE 
Manufacturer Contact
helen lewis
221 w. philadelphia st., ste 60
susquehanna commerce center w
york , PA 17401
7178457511
MDR Report Key4990628
Report Number3007362683-2015-00015
Device Sequence Number1
Product CodeEBG
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial
Report Date 03/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2015
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? Yes
Date Returned to Manufacturer03/27/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/20/2015
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: 08/06/2015 Patient Sequence Number: 1
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