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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. FOUNDATION SCREW; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. FOUNDATION SCREW; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 801-06540D
Device Problems Fracture (1260); Material Deformation (2976); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Event Description
It was reported that 4 mesa foundation screws broke and the inner collets got "stuck into the rod" intra-operatively.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This record will capture the third of four screws.
 
Manufacturer Narrative
Visual inspection: deformation was observed on the inner collet.Functional inspection: device was able to lock and unlock without issues.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Upon inspection of the returned device, deformation was observed on the inner collet, indicating issues during locking/unlocking.It was communicated by the initial reporter that a mesa rod unlocker, instead of a mesa rail unlocker, was used.It is likely that the use of a mesa rod unlocker on a rail created misalignment on the screw head during unlocking and excess loading, resulting in the observed deformation.The cause of the reported issue will be classified as 'deviation from surgical technique'.
 
Event Description
It was reported that 4 mesa foundation screws broke and the inner collets got "stuck into the rod" intra-operatively.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This record will capture the third of four screws.
 
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Brand Name
FOUNDATION SCREW; SIZE Ø6.5X40 MM
Type of Device
THORACOLUMBOSACRAL 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 Key12478048
MDR Text Key271658265
Report Number3004774118-2021-00277
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857136120
UDI-Public10888857136120
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number801-06540D
Device Catalogue Number801-06540D
Device Lot NumberGXXL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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