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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CADENCE IMPLANT-UNSPECIFIED CADENCE TOTAL ANKLE SYSTEM|

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INTEGRA LIFESCIENCES CORPORATION OH/USA CADENCE IMPLANT-UNSPECIFIED CADENCE TOTAL ANKLE SYSTEM| Back to Search Results
Catalog Number XXX-CADENCE IMPLANT
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)
Event Type  Injury  
Event Description
It was reported a radiographic review of a de-identified cadence x-ray was performed and suspected of presenting a fracture of the posterior malleolus of the tibia. The treating physician was contacted for confirmation of the fracture but stated that the radiograph did not demonstrate a fracture. On (b)(6) 2016, an integra surgeon consultant was then contacted via email to review the radiograph and to confirm that no fracture was present. The surgeon consultant indicated that the radiograph did in fact demonstrate a fracture. It was reported that although the device was in contact with the patient no patient injury is alleged. No revision or medical intervention was required. There was no delay in surgery.
 
Manufacturer Narrative
Integra completed its internal investigation 21dec2016. The investigation included: method: - review of device history records. - review of complaint management database for similar complaints. Results: the product id and lot number were not provided. The complaint report does not include the device lot number; therefore, a dhr review could not be conducted. A review of the complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received, determined three complaints of fractured tibial trays have been received. The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review. Complaint rate: (b)(4). Six instances of posterior tibia fractures have been identified indicating that an adverse trend is present. A corrective action has been initiated to determine root cause and develop a corrective action. Conclusion: the device was not returned to integra for evaluation. Because only an immediate post-operative x-ray was available, integra cannot definitively determine what caused this fracture. It is possible the fracture was caused during tibial tray insertion and it is possible the fracture was not caused during tibial tray insertion. When integra cannot definitively determine a complaint¿s root cause, its standard practice is to act conservatively and trend this complaint into all possible root causes.
 
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Brand NameCADENCE IMPLANT-UNSPECIFIED
Type of DeviceCADENCE TOTAL ANKLE SYSTEM|
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
cincinnati OH 45227
Manufacturer Contact
maria leonard
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6191712
MDR Text Key62912761
Report Number1651501-2016-00047
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K151459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-CADENCE IMPLANT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
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 Unkown

Patient Treatment Data
Date Received: 12/20/2016 Patient Sequence Number: 1
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