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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLUS IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 703710
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); Osteopenia/ Osteoporosis (2651)
Date of Event 06/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lot information unknown if it becomes available a follow-up report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), patient experienced failure of implant to integrate.
 
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Brand Name
REPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9529325
Report Number3001617766-2019-06235
Device Sequence Number2341278
Product Code DZE
UDI-Device Identifier10841307104193
UDI-Public10841307104193
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K073161
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 12/30/2019
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 Catalogue Number703710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/04/2019
Initial Report FDA Received Date12/30/2019
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 Age66 YR
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