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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 653716
Medical Device Problem Code Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes Purulent Discharge (1812); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 02/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4) , an intraoral infection was discovered when the patient presented for a dental implant crown impression.There was pus upon buccal palpitation.The patient was presented with the option of lanap treatment with a periodontist or implant removal.The implant was removed.Inflammation and osteopenia were also reported.
 
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Brand Name
INTERACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8453766
Report Number3001617766-2019-00098
Device Sequence Number13860045
Product Code DZE
UDI-Device Identifier10841307100423
UDI-Public10841307100423
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/16/2022
Device Catalogue Number653716
Device Lot Number93468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/26/2019
Initial Report FDA Received Date03/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age58 YR
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