DYNABLAST PASTE 1CC 10.210.1060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-19 for DYNABLAST PASTE 1CC 10.210.1060 manufactured by Keystone Dental.

Event Text Entries

[4124010] The clinician contacted keystone dental on (b)(6) 2013 and reported that a pt complained of a burning sensation immediately after placement of dyanblast paste. The graft was place done (b)(6) /2013, after immediate extraction at fdi-iso dental site 24. The pt returned for a one week post op visit on (b)(6) 2013 still complaining of burning. Examination revealed the surrounding area was red and sore. The implant and graft were removed.
Patient Sequence No: 1, Text Type: D, B5


[11466080] This product is contract manufactured for keystone dental by integra lifesciences. Keystone dental has an exclusive license to sell the dynablast product for dental applications from integra lifesciences, the developer of the product. No additional complaints from this lot were identified during a review of keystone complaints database. Integra performed a detailed review of the manufacturing records and verified that product was manufactured and released in accordance with the product specifications. Integra's review included the batch records, tissue bank donor record, demineralization record, and sterilization record. There were no anomalies found within these records. A review of the sterilization certificate of processing verified that the product was sterilized on (b)(6) 2012, in load 12h02 and was sterilized from dose 28. 4 kgy to 30. 9 kgy. The product was sterilized within specification of min dose 25. 0 kgy to max dose 35. 0 kgy. Sterigenics certifies the materials (products) received the indicated doses within the precision and accuracy of the dosimetry system employed. This product was sterilized to a sterility assurance level (sal) of 10-6. Keystone dental's investigation did not reveal any manufacturing or sterilization issues. The root cause of this incident could not be determined. Keystone dental considers this investigation closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005990499-2013-00008
MDR Report Key3529711
Report Source05,07
Date Received2013-11-19
Date of Report2013-10-21
Date of Event2013-09-17
Date Mfgr Received2013-10-21
Device Manufacturer Date2012-06-01
Date Added to Maude2014-01-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLIZ CACCIOLA, VP OPERATIONS
Manufacturer Street144 MIDDLESEX URNPIKE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7813283390
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDYNABLAST PASTE 1CC
Product CodeNUN
Date Received2013-11-19
Model NumberNA
Catalog Number10.210.1060
Lot Number120922
ID NumberNA
Device Expiration Date2014-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKEYSTONE DENTAL
Manufacturer AddressBURLINGTON MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-11-19

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