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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTGUIDE DRILL EXTENDER; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTGUIDE DRILL EXTENDER; DENTAL IMPLANT Back to Search Results
Catalog Number DGDE
Device Problem Positioning Problem (3009)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
Patient's identifier, age, sex, weight and other relevant history, including preexisting medical conditions were not provided.When the requested 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.
 
Event Description
Per complaint (b)(4), failure of latching function leads to failure of implant to integrate.
 
Manufacturer Narrative
This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation (b)(4).
 
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Brand Name
DIRECTGUIDE DRILL EXTENDER
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key10989964
MDR Text Key221483827
Report Number3001617766-2020-08684
Device Sequence Number1
Product Code DZI
UDI-Device Identifier10841307119111
UDI-Public10841307119111
Combination Product (y/n)N
PMA/PMN Number
K081396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDGDE
Device Lot Number170092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Date Manufacturer Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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