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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX INC PROVIEW MINIMAL ACESS PORTAL SYSTEM; FLEXIBLE ARM PROVIEW RETRACTOR SYSTEM
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ORTHOFIX INC PROVIEW MINIMAL ACESS PORTAL SYSTEM; FLEXIBLE ARM PROVIEW RETRACTOR SYSTEM Back to Search Results
Model Number 70-5002
Device Problem Sticking (1597)
Patient Problem Not Applicable (3189)
Event Date 05/15/2017
Event Type  malfunction  
Event Description
It was reported that the proview flexible arm was rigid and could not be used during the surgery.Another device had to be located to complete surgery which resulted in a delay in the case.There were on adverse events as a result of the delay and the surgery was completed as planned.
 
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Brand Name
PROVIEW MINIMAL ACESS PORTAL SYSTEM
Type of Device
FLEXIBLE ARM PROVIEW RETRACTOR SYSTEM
Manufacturer (Section D)
ORTHOFIX INC
3451 plano parkway
lewisville TX 75056
Manufacturer (Section G)
ORTHOFIX INC
3451 plano parkway
lewisville TX 75056
Manufacturer Contact
chenoa perez
3451 plano parkway
lewisville, TX 75056
2149372362
MDR Report Key6906177
MDR Text Key88131047
Report Number2183449-2017-00025
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number70-5002
Device Lot Number13788-KA07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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