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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SICAT GMBH & CO. KG SICAT IMPLANT V2.0 RADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNOSIS AND DENTAL IMPLANT PLANNING

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SICAT GMBH & CO. KG SICAT IMPLANT V2.0 RADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNOSIS AND DENTAL IMPLANT PLANNING Back to Search Results
Model Number SICAT IMPLANT V2.0
Device Problem Computer Software Problem (1112)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
Sicat implant v2. 0 is a standalone software application. The device problem was analyzed and it was found that implant planning data exported from sicat implant are not correct for one specific export format. A coding error was detected causing the device problem. Immediate action has been taken within the licensing system of sicat implantv 2. 0 to prevent new customers/users from activating the application. A field safety notice has be send out to the users and consignees of sicat implant v2. 0. The device will be corrected in the field by distributing and applying a software patch to remove the problem. Evaluation results and evaluation report will be provided in a follow-up report.
 
Event Description
Sicat implant is a standalone software application, i. E. A radiological visualization software for diagnosis and dental implant planning. A dentist found that implant planning data exported from sicat implant are not correct for one specific export format. If it were to recur, the error in the export format might cause dentists to manufacture (or have manufactured) surgical guides which are incorrect. Using those guides might cause drilling into the jaw to be either not deep enough or to deep. A dentist might have to stop a surgical procedure. Or the drilling when to deep might cause damage to structures within the jaw which need intervention.
 
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Brand NameSICAT IMPLANT V2.0
Type of DeviceRADIOLOGICAL VISUALIZATION SOFTWARE FOR DIAGNOSIS AND DENTAL IMPLANT PLANNING
Manufacturer (Section D)
SICAT GMBH & CO. KG
friesdorfer strasse 131-135
bonn, nrw 53175
GM 53175
Manufacturer Contact
manfred breuer
friesdorfer strasse 131-135
bonn, nrw 53175
GM   53175
MDR Report Key10331366
MDR Text Key229703370
Report Number3006098230-2020-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K192348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSICAT IMPLANT V2.0
Device Lot NumberV2.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number3006098230-2020-001

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