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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYINTERACTIVE DRIVER; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYINTERACTIVE DRIVER; DENTAL IMPLANT Back to Search Results
Catalog Number HT2.7LG
Device Problem Positioning Failure (1158)
Patient Problem Failure of Implant (1924)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Patient's identifier was not provided.When the requested information becomes available, a supplementary report will be submitted.Patient weight is unknown lot information is unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.
 
Event Description
Per complaint (b)(4), during clinical procedure, components could not be separated.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation.
 
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Brand Name
SIMPLYINTERACTIVE DRIVER
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key12024355
MDR Text Key257196374
Report Number3001617766-2021-03664
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119876
UDI-Public10841307119876
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHT2.7LG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2021
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
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