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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 Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Inflammation (1932); Pain (1994); Impaired Healing (2378)
Date of Event 03/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017.Report late due to asr to individual reporting transition.
 
Event or Problem Description
Per complaint (b)(4), patient reported pain and swelling.During clinical examination it was found that implant did not osseointegrate.Implant was removed.
 
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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 Key8979645
Report Number3001617766-2019-01764
Device Sequence Number365160
Product Code DZE
UDI-Device Identifier10841307100423
UDI-Public10841307100423
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 09/10/2019
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 Date05/21/2023
Device Catalogue Number653716
Device Lot Number114469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/24/2019
Initial Report FDA Received Date09/10/2019
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 Age74 YR
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