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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. SCREW; SIZE Ø5.5X25 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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K2M, INC. SCREW; SIZE Ø5.5X25 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR Back to Search Results
Model Number 2001-15525
Device Problems Unintended Ejection (1234); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2022
Event Type  malfunction  
Event Description
It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.This report will capture the screw.
 
Manufacturer Narrative
Device remains implanted in patient.
 
Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were observed.Based on available information, the screw difficult assembly was due to the angled tapered driver that came off the screw during insertion.
 
Event Description
It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.This report will capture the screw.
 
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Brand Name
SCREW; SIZE Ø5.5X25 MM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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 Key13655680
MDR Text Key287286602
Report Number3004774118-2022-00082
Device Sequence Number1
Product Code OVD
UDI-Device Identifier10888857025417
UDI-Public10888857025417
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092211
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 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2001-15525
Device Catalogue Number2001-15525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/09/2022
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 Sequence Number1
Patient Age60 YR
Patient SexFemale
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