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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 UNIQUE REFERENCE PER ORDER (CU
Device Problem Positioning Failure (1158)
Patient Problem Failure of Implant (1924)
Event Date 08/30/2023
Event Type  Injury  
Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.
 
Event Description
This event is for a surgiguide.The doctor states that she anesthetize the patient and did immediate extraction of tooth #9.When they placed the implant in she said just kept spinning.So, they grafted the site and closed it up.The doctor said she believes it should have been 2mm deeper into native bone in order to integrate with the bone.
 
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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 Key17877775
MDR Text Key325003606
Report Number3007362683-2023-00040
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
Report Date 10/05/2023
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 NumberUNIQUE REFERENCE PER ORDER (CU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date09/20/2023
Initial Date Manufacturer Received 09/20/2023
Initial Date FDA Received10/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2023
Type of Device Usage A
Patient Sequence Number1
Treatment
26315 ASTRATECH IMPL EV 3.6S 15MM OS
Patient Outcome(s) Required Intervention;
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