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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. UNKNOWN_K2M_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPE
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
This record captures a review of 'outcomes of percutaneous pedicle screw fixation for spinal trauma and tumours' from the journal of clinical neuroscience (http://dx. Doi. Org/10. 1016/j. Jocn. 2015. 05. 0460967-5868/). The article investigated the clinical and radiological results of percutaneous pedicle screw fixation in the management of spinal trauma and metastatic tumours. A retrospective analysis was performed on a series of 14 patients who were operated on from march 2009 to november 2011. The most frequently used system during this study was the denali mis system. One patient was treated using the mantis redux system. It was reported that one patient experienced 'misguided trajectory of a denali mis pedicle screw'. Additional information, including any consequences of this event, are not known.
 
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Brand NameUNKNOWN_K2M_PRODUCT
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key12089123
MDR Text Key269388732
Report Number3004774118-2021-00195
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SPE
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 Received07/30/2021
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: 06/29/2021 Patient Sequence Number: 1
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