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 2019-02-01 for ENDOBON? XENOGRAFT GRANULES 0.5ML N/A ROX05 manufactured by Biomet France S.a.r.l..

Event Text Entries

[134757383] (b)(4). Report source, foreign - event occurred in (b)(6). Concomitant medical products and therapy date detail of product: ref : og3040 - osseoguard tm resorbable collagen membrane 30 x 40 - (b)(4). According to the available data, the exact root cause of the event is likely the short delay between the implantation and the removal of the endobon, which did not enable the product to osseointegrate. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10


[134757384] It has been reported that the product endobon xenograft did not integrate. Endobon placement performed the (b)(6) 2018 and the product removal performed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006946279-2019-00086
MDR Report Key8297677
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-02-01
Date of Report2019-02-01
Date of Event2018-04-03
Date Mfgr Received2018-05-22
Device Manufacturer Date2017-12-06
Date Added to Maude2019-02-01
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. 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 Received2019-02-01
Model NumberN/A
Catalog NumberROX05
Lot NumberX0133342
Device Expiration Date2019-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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. Other 2019-02-01

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