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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC CANNULINK FIXATION SYSTEM INTRAOSSEOUS FIXATION SYSTEM

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TORNIER INC CANNULINK FIXATION SYSTEM INTRAOSSEOUS FIXATION SYSTEM Back to Search Results
Catalog Number UNAVAILABLE
Device Problems Migration or Expulsion of Device ; Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device. The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct. This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury. The source of this report is literature: article: seth h. Richman, md , marcelo bogliolo piancastelli siqueira, md , kirk a. Mccullough, md , and mark j. Berkowitz, md , correction of hammertoe deformity with novel intramedullary pip fusion device versus k-wire fixation. Foot & ankle international® 2017, vol. 38(2) 174-180. Doi: 10. 1177/1071100716671883.

 
Event Description

It was reported in a 2017 journal from richman, et al. , out of three patients not satisfied with the outcome from the implanted cannulink device, one patient developed a recurrent deformity (no revision surgery). Source - article: seth h. Richman, md , marcelo bogliolo piancastelli siqueira, md , kirk a. Mccullough, md , and mark j. Berkowitz, md , correction of hammertoe deformity with novel intramedullary pip fusion device versus k-wire fixation. Foot & ankle international® 2017, vol. 38(2) 174-180. Doi: 10. 1177/1071100716671883.

 
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Brand NameCANNULINK FIXATION SYSTEM
Type of DeviceINTRAOSSEOUS FIXATION SYSTEM
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
mary mcnabb
4375 e park 30 drive
columbia city , IN 46725
5743713153
MDR Report Key8970897
Report Number3004983210-2019-00046
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 09/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue NumberUNAVAILABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
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

Patient TREATMENT DATA
Date Received: 09/06/2019 Patient Sequence Number: 1
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