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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL SHORT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL SHORT; DENTAL IMPLANT Back to Search Results
Model Number HT2.5
Device Problem Failure to Osseointegrate (1863)
Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Per complaint (b)(4), during clinical procedure, the components could not be separated.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog #, udi#, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.Information for section a4, lot# were not available.When information becomes available, a supplemental report will be filed.Pma/510(k) not applicable.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
 
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Brand Name
HEX TOOL SHORT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9501787
MDR Text Key172191176
Report Number3001617766-2019-05949
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119630
UDI-Public10841307119630
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 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHT2.5
Device Catalogue NumberHT2.5S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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