ENDOBON XENOGRAFT GRANULES 0.5ML N/A ROX05

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-16 for ENDOBON XENOGRAFT GRANULES 0.5ML N/A ROX05 manufactured by Biomet France S.a.r.l..

Event Text Entries

[133181770] (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[133181771] It was reported that biomaterial was not integrated, so bone material was not compacted after placing the implant, resulting in implant failure. Biomaterial placed on (b)(6) 2017, implant placed on (b)(6) 2017 and non integration appeared on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006946279-2019-00042
MDR Report Key8251940
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-01-16
Date of Report2019-01-23
Date of Event2018-07-01
Date Mfgr Received2019-01-22
Device Manufacturer Date2015-07-23
Date Added to Maude2019-01-16
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 ContactMS. H BATAILLE
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE 26903
Manufacturer CountryFR
Manufacturer Postal26903
Manufacturer Phone0334757591
Manufacturer G1BIOMET FRANCE S.A.R.L.
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE CEDEX 26903
Manufacturer CountryFR
Manufacturer Postal Code26903
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameENDOBON XENOGRAFT GRANULES 0.5ML
Generic NameBONE GRAFTING MATERIAL, SYNTHETIC
Product CodeLYC
Date Received2019-01-16
Model NumberN/A
Catalog NumberROX05
Lot NumberV044208B
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET FRANCE S.A.R.L.
Manufacturer AddressPLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-01-16

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