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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST ® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST ® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number F2911-07540
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 04/08/2019
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) 2019 it was reported to k2m, inc.That a surgery took place in which a polyaxial screw did not perform according to specifications.Patient was revised on (b)(6) 2019.
 
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Brand Name
EVEREST ® SPINAL SYSTEM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
eva james
600 hope parkway se
leesburg, VA 20175
5719192080
MDR Report Key8567622
MDR Text Key143661987
Report Number3004774118-2019-00048
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberF2911-07540
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1001-E5545 LOT UNKNOWN; 2901-10001 LOT UNKNOWN; F2911-06540 LOT UNKNOWN
Patient Outcome(s) Required Intervention;
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