DEMINERALIZED BONE MATRIX (DMB) 0.5CC ROAP05

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-06-03 for DEMINERALIZED BONE MATRIX (DMB) 0.5CC ROAP05 manufactured by Biomet 3i.

Event Text Entries

[21540280] The doctor states he placed bone grafting material roap05 at tooth sight #20. Infection was seen 1 week post op and antibiotics were prescribed.
Patient Sequence No: 1, Text Type: D, B5


[21704828] Product remains implanted and will not be returned to manufacturer for evaluation. Single use.
Patient Sequence No: 1, Text Type: N, H10


[23605186] Method: - no testing methods performed unable to be selected. Results:? No results available since no evaluation performed unable to be selected. The product was not returned for evaluation, as it was used, therefore the complaint cannot be verified. The device history record review was completed by interpore cross. Product passed all quality control measures and no non-conformances were observed. The complaint lot history review was completed and no other complaints were reported. No deviations were identified through the investigation performed, that may have contributed to the reported event. A definitive root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001038806-2015-00694
MDR Report Key4815049
Report Source05,HEALTH PROFESSIONAL
Date Received2015-06-03
Date of Report2015-05-12
Date of Event2015-04-16
Date Mfgr Received2015-07-30
Device Manufacturer Date2014-07-22
Date Added to Maude2015-06-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 G1BIOMET 3I
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal Code33410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEMINERALIZED BONE MATRIX (DMB) 0.5CC
Generic NameALLOGRAFT PUTTY
Product CodeNUN
Date Received2015-06-03
Catalog NumberROAP05
Lot Number773420
Device Expiration Date2016-07-22
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET 3I
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-03

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