DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER ROAPM20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-17 for DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER ROAPM20 manufactured by Interpore Cross International.

Event Text Entries

[80128281] Device was discarded by the customer.
Patient Sequence No: 1, Text Type: N, H10


[80128282] The doctor reported that a patient had immediate socket grafting (roapm20) done in tooth location #13 on (b)(6) 2017. The patient returned on (b)(6) 2017 with severe pain, similar to dry socket pain. Loss of graft/non-integration was evident despite covering the site with crisscross sutures & resorbable collagen dressing. The extraction of the allograft was straight forward.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001038806-2017-00427
MDR Report Key6716676
Report SourceHEALTH PROFESSIONAL
Date Received2017-07-17
Date of Report2017-10-24
Date of Event2017-06-05
Date Mfgr Received2017-10-02
Date Added to Maude2017-07-17
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 FDA3
Event Location3
Manufacturer ContactMS. DANIA PEREZ
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5617766700
Manufacturer G1INTERPORE CROSS INTERNATIONAL
Manufacturer Street181 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 926182402
Manufacturer CountryUS
Manufacturer Postal Code926182402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
Generic NameALLOGRAFT PUTTY
Product CodeNUN
Date Received2017-07-17
Catalog NumberROAPM20
Lot Number009050
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTERPORE CROSS INTERNATIONAL
Manufacturer Address181 TECHNOLOGY DRIVE IRVINE CA 926182402 US 926182402


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-07-17

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