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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M INC. EVEREST® SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION
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K2M INC. EVEREST® SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION Back to Search Results
Catalog Number 2911-06545
Device Problems Break (1069); Fracture (1260)
Patient Problems Injury (2348); No Information (3190)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.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 two screws broke approximately 36 months post-operatively.Patient was revised (b)(6) 2018.
 
Event Description
On 12.03.2018, it was reported to k2m, inc.That two polyaxial screws broke approximately 36 months post-operatively.The patient was revised on (b)(6) 2018.
 
Manufacturer Narrative
The explanted screws were returned and inspected.Upon visual inspection, the returned screws are confirmed to be fractured.The fracture lines on both screws are superior to the center of the screw shank, and beach marks can be seen on the fracture surfaces which is indicative of fatigue fracture.It is possible that these screws fractured due to fatigue.These internal fixation devices serve as load bearing mechanisms which maintain alignment until healing has occurred.If there is a delay in healing or healing does not occur, then it is possible that the implant could eventually break, bend or loosen due to load bearing and/or residual motion.Per the warnings and precautions in the product insert, internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Manufacturing records were reviewed, and no relevant manufacturing issues were found.
 
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Brand Name
EVEREST® SPINAL SYSTEM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION
Manufacturer (Section D)
K2M INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key8189482
MDR Text Key131158166
Report Number3004774118-2018-00187
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 01/14/2020
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 Number2911-06545
Device Lot NumberEKCK,EMPA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Initial Date Manufacturer Received 12/03/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received12/18/2019
Supplement Dates FDA Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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