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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 1 IMPLANT; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

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DENTSPLY IMPLANTS N.V. SURGIGUIDE - 1 IMPLANT; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Back to Search Results
Catalog Number 37501
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
 
Event Description
The initial call was on (b)(6) 2023 the customer spoke with (b)(6) and explained to her that the guide had stability/fit issues when trying to use this guide.They did not proceed with the surgery.The initial call was disconnected.(b)(6) called the office back and left a voicemail, requesting somebody from the office to call back to get more details.Called doctor (b)(6) on 6/7 to about a different order when we finished.She asked what happened to order (b)(4).Then she explained what happened during the surgery.The doctor prepared for surgery extracted tooth and then proceeded to try in surgical guide.The doctor said it was rocking and there was space between the guide and teeth.So, she placed bone graft and didn't place implant.
 
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
SURGIGUIDE - 1 IMPLANT
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 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key17133539
MDR Text Key317205322
Report Number3007362683-2023-00032
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 10/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number37501
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/07/2023
Initial Date Manufacturer Received 06/07/2023
Initial Date FDA Received06/15/2023
Supplement Dates Manufacturer Received06/07/2023
Supplement Dates FDA Received10/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2023
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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