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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 Malposition of Device (2616)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
It was reported that while using a surgiguide to place three implants, the model initially sat fine in the patient's mouth.At the halfway point of drilling to place implant (b)(4), the guide began to rock and the doctor thought that it was bent.At this point implant (b)(4) was partially placed.The doctor trephined out implant (b)(4) because the implant wasn't in the planned position.The guide was removed and implant (b)(4) was not placed.
 
Manufacturer Narrative
Therefore, because an intervention was required, this event is reportable per 21 cfr part 803.
 
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Brand Name
SURGIGUIDE GUIDE
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 Key4961251
MDR Text Key6255991
Report Number3007362683-2015-00009
Device Sequence Number1
Product Code EBG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/25/2015
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 Manufacturer03/25/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2015
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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