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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 943308
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Failure of Implant (1924); Pain (1994)
Date of Event 01/18/2019
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), the patient experienced failure or loss of implant to integrate.Implant was removed and applied collagen plug.
 
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Brand Name
SWISHACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8987268
Report Number3001617766-2019-02692
Device Sequence Number16860748
Product Code DZE
UDI-Device Identifier10841307106593
UDI-Public10841307106593
Combination Product (Y/N)N
Initial Reporter CountryNL
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 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 Date11/02/2022
Device Catalogue Number943308
Device Lot Number103875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/21/2019
Initial Report FDA Received Date09/11/2019
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 Age69 YR
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