ENDOBON XENOGRAFT GRANULATES LARGE 8 ML N/A ROXLG80

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 GRANULATES LARGE 8 ML N/A ROXLG80 manufactured by Biomet France S.a.r.l..

Event Text Entries

[134752227] (b)(4). Report source, foreign - event occurred in (b)(6). The device will not be returned to the manufacturer. Therefore it will not be analyzed. The device history record has been reviewed. No discrepancies were found. With the available information, the exact root cause of the event could not be determined. 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


[134752228] The doctor reported an allergic reaction to endobon product. The doctor reported that sinus lift in tooth position 16 was performed on (b)(6) 2018. 7 days later, after medication treatment had already been finished, the patient developed an allergic reaction with exanthem and itch. The symptoms appeared in particular in the face, on the neck and cleavage, not in the patient mouth. Cortisone treatment was performed. As patient's condition did not improve, doctor removed completely the endobon product on (b)(6) 2018. Information on patient health status received the (b)(6) 2018 confirmed that the patient is well and the allergy has gone. 2 endobon products were involved in this event. The investigation for the second endobon product is performed in the report for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006946279-2019-00085
MDR Report Key8297519
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-02-01
Date of Report2019-02-01
Date of Event2018-05-24
Date Mfgr Received2018-05-25
Device Manufacturer Date2018-01-03
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 GRANULATES LARGE 8 ML
Generic NameBONE GRAFTING MATERIAL, SYNTHETIC
Product CodeLYC
Date Received2019-02-01
Model NumberN/A
Catalog NumberROXLG80
Lot NumberX0273004
Device Expiration Date2019-06-30
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. Required No Informationntervention 2019-02-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.