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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M INC. OZARK CERVICAL PLATE SYSTEM; CERVIAL PLATE SYSTEM
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K2M INC. OZARK CERVICAL PLATE SYSTEM; CERVIAL PLATE SYSTEM Back to Search Results
Catalog Number UNKNOWN
Device Problems Fracture (1260); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc.That a cervical plate broke approximately 1-3 months post-operatively.Component remains in the patient.
 
Manufacturer Narrative
It was reported that an ozark screw, implanted at the most caudal level of a 3-level ozark guide plate, was fractured at the neck post-operatively.The implant remains in the patient and was unavailable for evaluation.The product details could not be confirmed.The incident was confirmed through analysis of the relevant x-rays, but a root cause could not be determined.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc.That a cervical plate broke approximately 1-3 months post-operatively.Component remains in patient.
 
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Brand Name
OZARK CERVICAL PLATE SYSTEM
Type of Device
CERVIAL PLATE SYSTEM
Manufacturer (Section D)
K2M INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key8374615
MDR Text Key137304463
Report Number3004774118-2019-00021
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
PMA/PMN Number
K172104
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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