PEPGEN P-15 99U000102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-29 for PEPGEN P-15 99U000102 manufactured by Dentsply Tulsa Dental Specialties.

Event Text Entries

[6190685] In this event it was reported that pepgen p-15 bone grafting material pulled away from the extraction socket wall in a patient. The dentist removed the material and completed the procedure using another bone grafting material.
Patient Sequence No: 1, Text Type: D, B5


[13515369] Therefore, because intervention was required, this event is reportable per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2320721-2015-00008
MDR Report Key4961207
Report Source05
Date Received2015-07-29
Date of Report2014-11-26
Date Mfgr Received2014-11-26
Date Added to Maude2015-08-04
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 ContactHELEN LEWIS
Manufacturer StreetSUSQUEHANNA COMMERCE CTR W. 221 W. PHILADELPHIA ST., STE. 60
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePEPGEN P-15
Generic NameBONE GRAFTING MATERIAL
Product CodeNPZ
Date Received2015-07-29
Catalog Number99U000102
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY TULSA DENTAL SPECIALTIES
Manufacturer AddressJOHNSON CITY TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-07-29

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