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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL VENTIX LINK KNTLS 5.5MM MACH
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CAYENNE MEDICAL VENTIX LINK KNTLS 5.5MM MACH Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 10/27/2020
Event Type  Injury  
Manufacturer Narrative
Customer indicated that device was discarded by the hospital and will not be returned for evaluation.A follow up report will be submitted to rely any additional information.
 
Event Description
It was reported that patient underwent revision surgery to remove fractured anchors.No other patient harm was reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
VENTIX LINK KNTLS 5.5MM MACH
Type of Device
VENTIX
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
MDR Report Key10898411
MDR Text Key218261705
Report Number3006108336-2020-00030
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K180274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number110025992
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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