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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 37503
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 02/04/2015
Event Type  Injury  
Event Description
In this case, a customer planned to place three implants by the support of a surgiguide.Intraoperatively, the guide broke between the planned implants in region #13 and #14, when the dentist used the punch to remove soft tissue.Therefore, the dentist aborted the surgical treatment.
 
Manufacturer Narrative
Therefore, because treatment could not be completed, this event is reportable per 21 cfr part 803.The guide fracture was caused by a combination of an inaccurate plaster model and possible removal of too much material during production process.
 
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Brand Name
SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE
Type of Device
VARIOUS, 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 Key4961236
MDR Text Key21331615
Report Number3007362683-2015-00010
Device Sequence Number1
Product Code EBG
Combination Product (y/n)N
Reporter Country CodeFR
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 03/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number37503
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/17/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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