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

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.

• Brand Name: DIRECTGEN¿ PUTTY PLUS
• Type of Device: CORTICAL 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 Key: 7628220
• MDR Text Key: 112573768
• Report Number: 3001617766-2018-00157
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: DPP250
• Device Lot Number: THB60368292
• 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