• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT40X2 BONE CEMENT, ANTIBIOTIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT40X2 BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Information (3190)
Event Date 05/23/2016
Event Type  Malfunction  
Manufacturer Narrative

This user facility is outside of the united states. The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Quantity - 2. The following sections could not be completed with the limited information provided: manufacture date ¿ ni. Product location unknown.

 
Event Description

During an unknown procedure, the cement inner packaging had a hole causing the cement powder to leak. Due to the loss of powder, there was not enough cement to complete the procedure. There was no delay in the procedure. However, to complete the procedure, the surgeon used another type of cement with a higher antibiotic content. Due to the reported patient condition, the higher antibiotic content was not ideal.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREFOBACIN PLUS BONE CEMENT40X2
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
elisabeth plane
plateau de lautagne bp75
valence cedex 26903
FR   26903
0334757591
MDR Report Key5744397
MDR Text Key48008513
Report Number3006946279-2016-00196
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date11/30/2017
Device MODEL NumberN/A
Device Catalogue Number4021170001
Device LOT NumberA450A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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

-
-