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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 654306
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 03/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier, weight and explant date were not provided.When the requested information becomes available, a supplementary report will be submitted.Pma/510(k) - not applicable.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced failure of implant to integrate.
 
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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 Key10874530
Report Number3001617766-2020-08167
Device Sequence Number11470257
Product Code DZE
UDI-Device Identifier10841307100430
UDI-Public10841307100430
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 11/20/2020
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 Date04/23/2020
Device Catalogue Number654306
Device Lot Number63097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/24/2020
Initial Report FDA Received Date11/20/2020
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 Age48 YR
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