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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 2901-10001
Device Problems Device Slipped (1584); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 08/16/2018
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 09.04.2018 it was reported to k2m, inc that a revision took place in which a screw backed-out.Loosened, disengaged approximately 4 to 6 months post-operatively.A portion of the screw remains in the patient.Revision took place (b)(6) 2018.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc.That a revision took place in which a screw backed out.Loosend, disengaged approximately 4 to 6 months post-operatively.A portion of the screw remains in the patient.Revision took place (b)(6) 2018.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation, and a thorough investigation was completed.Upon further investigation it was concluded that the device did not contribute to this incident.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation, and a thorough investigation was completed.Upon review of the set screw, it was observed that the screw displayed radial damage consistent with the effects of reduction of the rod during tightening of the set screw.This can absorb the torque applied during the tightening phase, and allow for less than ideal locking forces.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc.That a revision took place in which a screw backed out.Loosend, disengaged approximately 4 to 6 months post-operatively.Revision took place (b)(6) 2018.
 
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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 VA 20175
MDR Report Key7904262
MDR Text Key121562498
Report Number3004774118-2018-00136
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
K132757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 08/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2901-10001
Device Lot NumberGGCJ
Was Device Available for Evaluation? No
Date Manufacturer Received09/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
1001-E5550, LOT FNXK; 1001-E5550, LOT FNXK; 1001-E5550, LOT FNXK; 2901-10001, LOT GGCJ; 2901-10001, LOT GGCJ; E5112-06540 LOT GGXY; E5112-07540, LOT EWGW; E5112-07540, LOT EWGW; E5112-07540, LOT EWGW
Patient Outcome(s) Required Intervention;
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