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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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K2M, INC. SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 201-14016C
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2024
Event Type  Injury  
Event Description
A patient underwent revision surgery approximately three months post-operatively to address two fractured pyrenees constrained self-tapping screws at c7.This report captures the second of two pyrenees constrained self-tapping screws.
 
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Brand Name
SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 MM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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 Key18679118
MDR Text Key335074265
Report Number3004774118-2024-00007
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number201-14016C
Device Lot NumberTKVH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2024
Date Manufacturer Received01/12/2024
Was Device Evaluated by Manufacturer? No
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 Outcome(s) Required Intervention;
Patient Age40 YR
Patient SexFemale
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