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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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DENTSPLY IMPLANTS N.V. SURGIGUIDE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Catalog Number 37504
Device Problem Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2016
Event Type  Injury  
Manufacturer Narrative
Because this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
It was reported that a surgiguide was used to place four dental implants.Two of the implants were placed without issues.However, the implants planned in the areas of #20 and 21 were placed so far buccal that they lacked sufficient primary stability.A corrective surgery is now required.
 
Manufacturer Narrative
The device was not returned as indicated in the initial report.Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
SURGIGUIDE
Type of Device
SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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 Key5698678
MDR Text Key46568345
Report Number3007362683-2016-00004
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113739
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 04/26/2016
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? Yes
Device Operator Health Professional
Device Catalogue Number37504
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/30/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2016
Initial Date FDA Received06/03/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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