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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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)
Event Type  Injury  
Event Description
It was reported the surgeon appreciated a fracture of the posterior malleolus during a 6 week (postoperative) follow up visit. The fractured was identified via lateral x-ray. It was reported that patient injury was unknown. Additional information was received. The patient underwent a total ankle arthroplasty using the cadence taa approximately 6 weeks prior ((b)(6) 2016). X-ray confirmed a fracture of the posterior malleolus. The surgeon reports he does not feel the fracture is a result of a failure of the device. He reports he does not anticipate any functional problem for the patient due to the incident. The patient followed postoperative instructions. Revision surgery is not planned. The device appears to be functioning well. The patient is feeling well. The patient¿s current condition is ¿normal post operative course. ¿.
 
Manufacturer Narrative
Integra completed its internal investigation 13dec2016. The investigation included: method: - review of device history records. - review of complaint management database for similar complaints. Results: 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 during the lifetime of the product. 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). Conclusion: the device was not returned to integra for evaluation. The most probable root cause for the presence of a tibial posterior fracture is when the implant is inserted and impacted at an angle resulting in the fins fracturing the bone.
 
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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 Key6143020
MDR Text Key61401313
Report Number1651501-2016-00046
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 Dental Hygienist
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
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: 12/02/2016 Patient Sequence Number: 1
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