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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. MGUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
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DENTSPLY IMPLANTS N.V. MGUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Back to Search Results
Catalog Number MG-STN6
Device Problem Malposition of Device (2616)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Because a serious injury resulted, this event is reportable per 21 cfr part 803.The dhr of (b)(4) has been checked, implant position 24 has minimal bone available.However, the implant is planned as good as possible at the requested position.Guide is wobbling on the model.Design of the guide looks correct.
 
Event Description
The implant on position 24 went buccally outside the bone.The doctor stopped the surgery immediately and covered the destroyed bone with membrane.The patient didn't get the implant at this position.
 
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Brand Name
MGUIDE
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
Manufacturer (Section G)
DENTSPLY IMPLANTS N.V.
research campus 10
hasselt limburg, B-350 0
BE   B-3500
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
york, PA 17401
7178494593
MDR Report Key13588195
MDR Text Key289982880
Report Number3007362683-2022-00002
Device Sequence Number1
Product Code NDP
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
NA
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 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMG-STN6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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