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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
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DENTSPLY IMPLANTS N.V. SURGIGUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Back to Search Results
Catalog Number 37505
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Additional surgery will be planned accordingly.After this corrective measure the patient will not suffer from any permanent harm.Because this event resulted in a serious injury, it is reportable per 21cfr part 803.The device was evaluated and found to be within specification.
 
Event Description
During creation of the osteotomies for implants in the anterior region (27, 25 and 23) using a surgiguide, the lingual plate of the bone was fenestrated near to the occlusal side of the implant.The doctor decided to abort the drilling and restored the bone ridge using grafting material.The patient was sent home for a healing period of 6 months.
 
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Brand Name
SURGIGUIDE
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
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7088210
MDR Text Key93893724
Report Number3007362683-2017-00003
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number37505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/06/2017
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
Treatment
DRILL
Patient Outcome(s) Required Intervention;
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