MAUDE Adverse Event Report: KEYSTONE DENTAL INC DYNABLAST PASTE 0.5CC

Catalog Number	10.210.1050
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
This clinician contacted keystone dental on 12/15/2016 to report that a patient receiving dyanblast paste following an immediate extraction and grafting procedure 2 weeks prior had complained of pain, numbness, and swelling at the grafting site.According to the incident narrative, the tooth at fdi-iso dental site 36, was extracted on (b)(6) 2016 immediate placement of an implant and grafted around the implant with dynablast paste.On 12/12/2016, the patient reported that the numbness and pain were improving but not completely resolved.The clinician reported the t the implant was healing well with out issue.

• Brand Name: DYNABLAST PASTE 0.5CC
• Common Device Name: DYNABLAST PASTE 0.5CC
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex tpk; burlington MA 01803 4403
• MDR Report Key: 6254528
• Report Number: 3005990499-2016-00008
• Device Sequence Number: 10985564
• Product Code: NUN
• UDI-Device Identifier: D7681021010500
• UDI-Public: D7681021010500
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K043573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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: Dentist
• Device Expiration Date: 03/28/2018
• Device Catalogue Number: 10.210.1050
• Device Lot Number: 155744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR