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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 37504
Device Problem Positioning Failure
Event Type  Injury  
Manufacturer Narrative

Because a second intervention is necessary, this event is reportable per 21 cfr part 803.

 
Event Description

In this case, a dentist planned to place two different implant systems (2 xive and 4 ankylos) in one patient. The dentist ordered one surgiguide with an ankylos configuration including the tubes for both systems. However, this is not possible with simplant. The second implant system was identified as a "3. 0 fixation screw", which is not the same as the desired xive implant. In these cases, and to avoid any confusion, it is necessary to order two separate guides, one for each system to be used. The clinician stopped the surgery with just four implants (ankylos) placed.

 
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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 Key4990627
Report Number3007362683-2015-00016
Device Sequence Number1
Product CodeEBG
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial
Report Date 05/28/2015
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 Number37504
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2015
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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