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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC OVERDENTURE ABUTMENT; DENTAL ABUTMENT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC OVERDENTURE ABUTMENT; DENTAL ABUTMENT Back to Search Results
Catalog Number 1037-61
Device Problem Fracture (1260)
Patient Problem Impaired Healing (2378)
Event Date 10/20/2018
Event Type  malfunction  
Event Description
Per complaint (b)(4), there was a fracture on a multi-unit abutment four months after initial placement of a patient's dental implant.The abutment was removed.
 
Manufacturer Narrative
Corrected event type from serious injury to malfunction.
 
Event Description
Per complaint (b)(4), there was a fracture on a multi-unit abutment four months after initial placement of a patient's dental implant.The abutment was removed.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation.(b)(4).
 
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Brand Name
OVERDENTURE ABUTMENT
Type of Device
DENTAL ABUTMENT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e. hillcrest dr.
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key8167746
MDR Text Key130464352
Report Number3001617766-2018-00378
Device Sequence Number1
Product Code NHA
UDI-Device Identifier10841307114857
UDI-Public10841307114857
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K061319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Type of Report Initial,Followup,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/19/2020
Device Catalogue Number1037-61
Device Lot Number69602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2015
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 Outcome(s) Required Intervention;
Patient Age64 YR
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