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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M INC. EVEREST® SPINAL SYSTEM; ORTHOSIS, SPINAL FIXATION SYSTEM
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K2M INC. EVEREST® SPINAL SYSTEM; ORTHOSIS, SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 2911-05550
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problems Injury (2348); No Information (3190)
Event Date 01/01/2019
Event Type  Injury  
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) 2019 it was reported to k2m, inc.That two screws backed-out, loosened or disengaged approximately 1 month post-operatively.The patient was revised on (b)(6) 2019.
 
Manufacturer Narrative
Manufacturing records could not be reviewed as lot numbers were unavailable.Imaging was not provided and the devices were not returned for analysis.There is insufficient information with which to establish a potential root cause.
 
Event Description
It was reported that two everest polyaxial screws fractured.Patient was revised on (b)(6) 2019.
 
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Brand Name
EVEREST® SPINAL SYSTEM
Type of Device
ORTHOSIS, SPINAL FIXATION SYSTEM
Manufacturer (Section D)
K2M INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key8334935
MDR Text Key136000407
Report Number3004774118-2019-00009
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2911-05550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/13/2019
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received01/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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