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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; HEX WRENCH
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; HEX WRENCH Back to Search Results
Catalog Number HT2.5LG
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Per complaint (b)(4), the implant driver is too retentive.The clinician has to hold the carrier with rongeurs to remove the mount.When placing the driver directly in the implant, the implant comes out when tool removal is attempted.In soft bone, the implant pulls out.Additionally, per the complaint, the color coding on the tools has won out.
 
Manufacturer Narrative
Additional information requested on 09/24/2019.On 10/03/2019, information received.Per the complaint, there were 5 patient cases affected, resulting in buccal plate fractures.Patient identifier, event date was not provided.This complaint is also linked to mdr 3001617766-2019-00259.Follow-up submitted to report device evaluation.
 
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Brand Name
SIMPLYLEGACY DRIVER
Type of Device
HEX WRENCH
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest dr.
thousand oaks CA 91362
MDR Report Key8679961
MDR Text Key147379183
Report Number3001617766-2019-00260
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119852
UDI-Public10841307119852
Combination Product (y/n)N
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 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHT2.5LG
Device Lot Number122943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Initial Date Manufacturer Received 05/09/2019
Initial Date FDA Received06/07/2019
Supplement Dates Manufacturer Received10/03/2019
Supplement Dates FDA Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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