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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 40X1 BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 40X1 BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source, foreign - event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the sealing of sterile pack was found broken before the surgery.

 
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Brand NameREFOBACIN BONE CEMENT R 40X1
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer Contact
christina arnt
56 e. bell dr.
valence, IN 46582
5745273773
MDR Report Key8151233
MDR Text Key130050312
Report Number3006946279-2018-00382
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup,Followup
Report Date 04/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2020
Device MODEL NumberN/A
Device Catalogue Number4003940001
Device LOT NumberA748BA0806
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/19/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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