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

Catalog Number 10.210.1050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event 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
• Type of Device: DYNABLAST PASTE 0.5CC
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex tpk; burlington MA 01803 4403
• Manufacturer (Section G): KEYSTONE DENTAL INC; 154 middlesex tpk; burlington MA 01803 4403
• Manufacturer Contact: josh harkess ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283526
• MDR Report Key: 6254528
• MDR Text Key: 64922807
• Report Number: 3005990499-2016-00008
• Device Sequence Number: 1
• Product Code: NUN
• UDI-Device Identifier: D7681021010500
• UDI-Public: D7681021010500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 03/28/2018
• Device Catalogue Number: 10.210.1050
• Device Lot Number: 155744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR