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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 Disconnection (1171); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2019
Event Type  malfunction  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was confirmed via post-op x-ray a disconnection between a mesa rod and screw. No complaints from the patient. No plans for revision surgery.
 
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Brand NameUNKNOWN_K2M_PRODUCT
Type of DeviceTHORACOLUMBOSACRAL 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
margarita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key9050273
MDR Text Key178322508
Report Number3004774118-2019-00093
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SPE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2019
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

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