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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLUS IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 924108
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Inflammation (1932)
Date of Event 04/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted if the information becomes available.
 
Event or Problem Description
Per complaint (b)(4), patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
 
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Brand Name
SWISHPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9871154
Report Number3001617766-2020-02959
Device Sequence Number524885
Product Code DZE
UDI-Device Identifier10841307106135
UDI-Public10841307106135
Combination Product (Y/N)N
Initial Reporter CountrySW
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 11/10/2020
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 Date01/31/2024
Device Model Number924108
Device Catalogue Number924108
Device Lot Number131961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Initial Date Received by Manufacturer 02/25/2020
Supplement Date Received by Manufacturer03/31/2020
Initial Report FDA Received Date03/24/2020
Supplement Report FDA Received Date11/10/2020
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;
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