COPIOS CANCELLOUS XENOGRAFT PARTICLES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-06-16 for COPIOS CANCELLOUS XENOGRAFT PARTICLES manufactured by Rti Surgical, Inc.

Event Text Entries

[47559593] Method: the graft was not returned for evaluation. Therefore, a re-review was performed of the manufacturing records, sterilization run reports, environmental monitoring results, quality control/assurance reviews and release, and the complaints database for related complaints associated wit the lot. Results: there was one deviation noted for lot# nz-162-24-05-12 related to instrumentation during receipt of bovine tissue. After, investigation it was determined there was no risk associated to tissue and the tissue was approved for further processing. The graft underwent a validated sterilization methodology; tutoplast? Which includes terminal sterilization by gamma irradiation after packaging. Environmental data and records generated during and around the time of processing for this lot were acceptable. To date (b)(4) has distributed (b)(4) xenografts from this lot without related complaints for the lot. Conclusion: given the fact that: the device was not returned for evaluation; records review demonstrated no deviations that had a negative impact during manufacturing of graft id (b)(4); the graft met specification requirements and release criteria at the time of distribution; and no related complaints were noted associated with distributed grafts from this lot, it is unlikely that this event is related to the xenograft.
Patient Sequence No: 1, Text Type: N, H10


[47559594] (b)(4) and tutogen medical (b)(4), a wholly owned subsidiary of (b)(4), received a report from the (b)(6) authority directly from the customer that an infection was noted. No other details were provided.
Patient Sequence No: 1, Text Type: D, B5


[48966912] Report submitted 06/16/16 in error. Copios cancellous xenograft particles are distributed rest of world and (b)(4) does not distribute the same or similar products in the united states, therefore, no reporting is required
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002924436-2016-00004
MDR Report Key5730218
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2016-06-16
Date of Report2016-06-16
Date of Event2016-05-17
Date Mfgr Received2016-05-20
Device Manufacturer Date2014-10-31
Date Added to Maude2016-06-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS CHARITY EMMONS
Manufacturer Street11621 RESEARCH CIRCLE
Manufacturer CityALACHUA FL 32615
Manufacturer CountryUS
Manufacturer Postal32615
Manufacturer Phone3864188888
Manufacturer G1RTI SURGICAL, INC
Manufacturer Street11621 RESEARCH CIRCLE
Manufacturer CityALACHUA FL 32615
Manufacturer CountryUS
Manufacturer Postal Code32615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOPIOS CANCELLOUS XENOGRAFT PARTICLES
Generic NameXENOGRAFT CANCELLOUS PARTICLES
Product CodeLPK
Date Received2016-06-16
Lot NumberNZ-162-24-05-12
Device Expiration Date2019-09-30
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRTI SURGICAL, INC
Manufacturer Address11621 RESEARCH CIRCLE ALACHUA FL 32615 US 32615


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-06-16

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