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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 753710
Device Problems Separation Failure (2547); Component or Accessory Incompatibility (2897)
Patient Problem Failure of Implant (1924)
Event Date 02/20/2021
Event Type  malfunction  
Manufacturer Narrative
Patient's age was not provided.When the requested information becomes available, supplementary report will be submitted.
 
Event Description
Per complaint (b)(4), during clinical procedure, components could not be separated.
 
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Brand Name
REACTIVE IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
karen manalili
3050 east hillcrest drive
thousand oaks, CA 91362
8057785914
MDR Report Key11495316
MDR Text Key240084166
Report Number3001617766-2021-01696
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307103592
UDI-Public10841307103592
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number753710
Device Lot Number163378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2020
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 Weight54
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