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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE HEALING COLLAR; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE HEALING COLLAR; DENTAL IMPLANT Back to Search Results
Catalog Number 6534-15
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Sinus Perforation (2277); Fibrosis (3167)
Date of Event 02/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lot information is unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss of implant to osseointegrate.
 
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Brand Name
INTERACTIVE HEALING COLLAR
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key11445923
Report Number3001617766-2021-01627
Device Sequence Number3513393
Product Code NHA
UDI-Device Identifier10841307109884
UDI-Public10841307109884
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K130572
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/09/2021
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 Catalogue Number6534-15
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/24/2021
Initial 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 Age68 YR
Patient Weight86
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