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

MAUDE Adverse Event Report: BIOMET UK LTD. REFOBACIN REVISION 1X40G 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 UK LTD. REFOBACIN REVISION 1X40G BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 06/22/2016
Event Type  Malfunction  
Manufacturer Narrative

This user facility is outside of the united states. The necessary manufacturing history to review was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Zimmer biomet (b)(4) and package supplier are in the process of initiating modifications. Product location unknown.

 
Event Description

It was reported that when box of bone cement was opened, the package of powder was leaking. There was no patient involvement and no delay in a procedure as a result of the event.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Udi - (b)(4). Product return date - ni. (b)(4). Corrective action has been initiated for the reported issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREFOBACIN REVISION 1X40G
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
daniel tilbury
waterton industrial estates
bridgend 
0441656655
MDR Report Key5811965
MDR Text Key51123464
Report Number3002806535-2016-00572
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 06/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date10/31/2018
Device MODEL NumberN/A
Device Catalogue Number3011630001
Device LOT NumberA545AI2903
OTHER Device ID NumberSEE NARRATIVE IN H10
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2016
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

-
-