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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 754708
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 07/07/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4) implant loss integration.Patient experienced no injury.
 
Additional Manufacturer Narrative
This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).
 
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Brand Name
REACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e hillcrest dr.
thousand oaks, ca
MDR Report Key10440165
Report Number3001617766-2020-06228
Device Sequence Number11432019
Product Code DZE
UDI-Device Identifier10841307103684
UDI-Public10841307103684
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 03/08/2021
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 Date01/15/2020
Device Model Number754708
Device Catalogue Number754708
Device Lot Number59613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Initial Date Received by Manufacturer 07/24/2020
Supplement Date Received by Manufacturer09/18/2020
Initial Report FDA Received Date08/21/2020
Supplement Report FDA Received Date03/09/2021
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 Age72 YR
Patient Weight73
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