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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE; VARIOUS
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DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE; VARIOUS Back to Search Results
Catalog Number 37504
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Code Available (3191)
Event Date 02/09/2015
Event Type  Injury  
Event Description
A simplant surgiguide was used to place four implants in the mandible.The implant in region 35 (# 20) was not covered with bone lingually when placed into final position.Thus the dentist removed it and replaced it in the same session with an implant in region 36 (#19) instead, without using a guide.
 
Manufacturer Narrative
This event required intervention and therefore meets the criteria for reportability per 21 cfr part 803.The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.
 
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Brand Name
SURGIGUIDE GUIDE
Type of Device
VARIOUS
Manufacturer (Section D)
DENTSPLY IMPLANTS N.V.
hasselt limburg
BE 
Manufacturer Contact
helen lewis
susquehanna commerce ctr w
221 w philadelphia st ste 60
york, PA 17401
7178457511
MDR Report Key4658444
MDR Text Key5683986
Report Number3007362683-2015-00002
Device Sequence Number1
Product Code EBG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number37504
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2014
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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