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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40X2 BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40X2 BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). The product within this report is a combination product. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Other not returned to manufacturer.

 
Event Description

It was reported the cement inner sterile packaging was ripped, allowing the cement powder to pour out. No patient consequences or additional information were reported.

 
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Brand NameBIOMET BONE CEMENT R 40X2
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
hélène bataille
plateau de lautagne bp75
valence, IN 26903
FR   26903
5745273773
MDR Report Key7096486
MDR Text Key95081823
Report Number3006946279-2017-00278
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeEZ
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 12/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number4035890022
Device LOT NumberA609AF1307
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/06/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2016
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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