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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTGEN¿ PUTTY PLUS CORTICAL BONE VOLUME DENTAL PUTTY

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IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTGEN¿ PUTTY PLUS CORTICAL BONE VOLUME DENTAL PUTTY Back to Search Results
Catalog Number DPP250
Device Problems Device Expiration Issue (1216); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2018
Event Type  malfunction  
Event Description
Per the complaint, the patient was in ofc for wall defect. The doctor opened dpp250 and upon completing treatment, realized that the sticker indicated that the product was expired. It expired 02/02/2018.
 
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Brand NameDIRECTGEN¿ PUTTY PLUS
Type of DeviceCORTICAL BONE VOLUME DENTAL PUTTY
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key7628220
MDR Text Key112573768
Report Number3001617766-2018-00157
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue NumberDPP250
Device Lot NumberTHB60368292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/22/2018 Patient Sequence Number: 1
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