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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNKNOWN MESA SCREW POSTERIOR CERVICAL SCREW SYSTEM

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K2M, INC. UNKNOWN MESA SCREW POSTERIOR CERVICAL SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2016
Event Type  Injury  
Manufacturer Narrative
Remains implanted.
 
Event Description
It was reported via clinical study that a patient experienced a dural tear during the procedure. The tear was repaired during the index surgery and the patient's hospital stay was extended.
 
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Brand NameUNKNOWN MESA SCREW
Type of DevicePOSTERIOR CERVICAL 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 Key12510108
MDR Text Key272695655
Report Number3004774118-2021-00284
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
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
Date Manufacturer Received12/13/2021
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: 09/21/2021 Patient Sequence Number: 1
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