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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 604313U
Medical Device Problem Codes Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 05/02/2018
Type of Reportable Event Malfunction
Event or Problem Description
Per (b)(4), there was a packaging error.In the vial there was what appeared to be an abutment instead of an implant.
 
Event or Problem Description
(b)(4), there was a packaging error.In the vial there was what appeared to be an abutment instead of an implant.
 
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Brand Name
SIMPLY REPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key7723419
Report Number3001617766-2018-00174
Device Sequence Number789640
Product Code DZE
UDI-Device Identifier10841307108313
UDI-Public10841307108313
Combination Product (Y/N)N
Initial Reporter StateID
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date01/23/2023
Device Catalogue Number604313U
Device Lot Number108191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Initial Date Received by Manufacturer 05/08/2018
Supplement Date Received by Manufacturer05/08/2018
Initial Report FDA Received Date07/26/2018
Supplement Report FDA Received Date07/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		3001617766071920180006R
Patient Sequence Number1
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