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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 5101-90107
Device Problems Break (1069); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been 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 a cannulated driver broke at the tip during removal.Surgery took 1 hour and 30 minutes.There was a significant delay of 30 minutes.
 
Manufacturer Narrative
The broken tip was successfully removed from the patient.Manufacturing and inspection records of the subject lot was reviewed and no relevant discrepancies were found.Upon review of the cannulated driver, it was observed that the distal tip was sheared at the hexalobe feature in a counterclockwise deformity pattern, indicating the incident occurred during the removal maneuver.The fracture face was smooth and uniform, suggestive of sudden brittle fracture.It is likely the cannulated driver experienced increased torsional load while removing the screw.
 
Event Description
On 03.07.2019 it was reported to k2m, inc.That a cannulated driver broke at the tip during removal.Surgery took 1 hour and 30 minutes.There was a significant delay of 30 minutes.
 
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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 Key8665003
MDR Text Key146947119
Report Number3004774118-2019-00060
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5101-90107
Device Lot NumberHCAV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2019
Date Manufacturer Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
1001-E5545: LOT FMAE; 2901-10001 LOT FGGV; 2901-10001 LOT FEFH; 2901-10001: LOT FGGW; F2911-06540 LOT FVCC; F2911-07540 LOT FPVY
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