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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPAIN, S.L. VAST.F40 NON CEM COLLAR T12 PROSTHESIS, HIP

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BIOMET SPAIN, S.L. VAST.F40 NON CEM COLLAR T12 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4) (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
 
Event Description
It was reported the sterile packaging was unsealed. The surgery was completed with another device with no reported delay to surgery. No further information has been made available at this time.
 
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Brand NameVAST.F40 NON CEM COLLAR T12
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET SPAIN, S.L.
calle islas baleares, #50
p.o. box 96
fuente del jarro, valencia 46988
SP 46988
Manufacturer (Section G)
BIOMET SPAIN, S.L.
calle islas baleares, #50
p.o. box 96
fuente del jarro, valencia 46988
SP 46988
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7183394
MDR Text Key97885644
Report Number0009610576-2018-00001
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF40NC12
Device Lot Number2015111966
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 Received12/18/2017
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

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