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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 HT1.25S
Device Problem Defective Device (2588)
Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Event Date 11/06/2019
Event Type  malfunction  
Event Description
Per complaint (b)(4), ht1.25s and ht1.25 hex tool bent while removing healing cap.
 
Manufacturer Narrative
Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.Information for section a4 was not available.When information becomes available, a supplemental report will be filed.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 Key9389850
MDR Text Key168603855
Report Number3001617766-2019-05420
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119678
UDI-Public10841307119678
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 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/06/2021
Device Model NumberHT1.25S
Device Catalogue NumberHT1.25S
Device Lot Number76684
Was Device Available for Evaluation? No
Date Manufacturer Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age27 YR
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