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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOB BN CMT R BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOB BN CMT R 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 06/28/2016
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. Discarded.

 
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. (b)(4). Corrective action has been initiated for the reported issue.

 
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Brand NameOPTIPAC-S 60 REFOB BN CMT R
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 
0334757591
MDR Report Key5834918
MDR Text Key50816804
Report Number3006946279-2016-00259
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
Type of Report Initial,Followup
Report Date 06/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date07/31/2017
Device MODEL NumberN/A
Device Catalogue Number4711500396-1
Device LOT NumberA548C10465
OTHER Device ID NumberSEE NARRATIVE IN H10
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 Received12/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2016
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

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