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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SIMPLANT GUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
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DENTSPLY IMPLANTS N.V. SIMPLANT GUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Back to Search Results
Catalog Number 37502
Device Problem Malposition of Device (2616)
Patient Problems Failure of Implant (1924); Perforation (2001)
Event Type  Injury  
Manufacturer Narrative
This event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
The clinician used a simplant universal guide to create the osteotomy for implants 1 and 2 in combination with the universal surgery kit.The buccal plate of the bone was perforated while using the guide.The patient is ok and will not suffer permanent harm.Doctor said the guidance was about 2mm off from what he had planned.
 
Manufacturer Narrative
The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.
 
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Brand Name
SIMPLANT GUIDE
Type of Device
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
Manufacturer (Section D)
DENTSPLY IMPLANTS N.V.
research campus 10
hasselt limburg, B-350 0
BE  B-3500
MDR Report Key12036672
MDR Text Key257372899
Report Number3007362683-2021-00002
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number37502
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/21/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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