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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M INC. EVEREST XT; PEDICLE SCREW SPINAL SYSTEM
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K2M INC. EVEREST XT; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/12/2018
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) 2018 it was reported to k2m, inc.That two everest polyaxial screws disassembled prematurely at the welds.The malfunction resulted in a significant delay to surgery.
 
Event Description
On 07.20.2018 it was reported to k2m, inc.That two everest polyaxial screws disassembled prematurely at the welds.The malfunction resulted in a significant delay to surgery.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the screws remain in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.
 
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Brand Name
EVEREST XT
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
K2M INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key7786774
MDR Text Key117256285
Report Number3004774118-2018-00127
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
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