ENDOBON N/A ROX05

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-18 for ENDOBON N/A ROX05 manufactured by Biomet France S.a.r.l..

Event Text Entries

[73057689] Cmp-(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[73057690] It was reported a patient experienced burning and irritation as a result of the bone grafting. As a result, the bone graft was removed and replaced with a different product.
Patient Sequence No: 1, Text Type: D, B5


[108190646] This follow-up report is being submitted to relay additional information. (b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. 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


MAUDE Entry Details

Report Number3006946279-2017-00067
MDR Report Key6500638
Report SourceHEALTH PROFESSIONAL
Date Received2017-04-18
Date of Report2017-07-06
Date of Event2017-02-15
Date Mfgr Received2017-06-06
Device Manufacturer Date2016-07-01
Date Added to Maude2017-04-18
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. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
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
Generic NameBONE GRAFTING MATERIAL, SYNTHETIC
Product CodeLYC
Date Received2017-04-18
Model NumberN/A
Catalog NumberROX05
Lot NumberW0085186
ID NumberSEE H10 NARRATIVE
Device Expiration Date2017-12-31
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
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 2017-04-18

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