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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GODIRECT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC GODIRECT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 433011L
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Wound Dehiscence (1154); Failure of Implant (1924); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 12/30/2017
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), during post operative check it was observed that patient experienced bone loss and inflammation.Implant failed to integrate.
 
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Brand Name
GODIRECT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8989584
Report Number3001617766-2019-02823
Device Sequence Number2547545
Product Code DZE
UDI-Device Identifier10841307122180
UDI-Public10841307122180
Combination Product (Y/N)N
Initial Reporter CountrySI
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 09/11/2019
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 Date04/14/2021
Device Catalogue Number433011L
Device Lot Number77163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/01/2019
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 Age65 YR
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