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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.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was not specified if the screw was mantis or denali screw.Both type of screws can be inserted over a k wire.No patient harm was reported due to this event.No additional information was provided upon multiple follow ups.Stryker surgical technique provides detail steps on preparing pedicle pathways and inserting the screw.The surgeon is to be thoroughly familiar with the surgical procedure, instruments, and implant characteristics prior to performing surgery.Misguiding the screw during the procedure is most likely associated with user error and not failure of device itself.Among with misguided screw, k wire breach was reported.Since the screw is inserted over a k wire, improper position/placement of the k wire most likely caused misguiding of the screw.
 
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 Name
UNKNOWN_K2M_PRODUCT
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key12089123
MDR Text Key269388732
Report Number3004774118-2021-00195
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
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 Health Professional
Device Catalogue NumberUNK_SPE
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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