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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M. INC MESA SPINAL SYSTEM; PEDICLE SCREW SYSTEM
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K2M. INC MESA SPINAL SYSTEM; PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 6201-095100
Device Problems Device Slipped (1584); Migration (4003)
Patient Problem No Information (3190)
Event Date 07/16/2018
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.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 a revision surgery took place in which a backed-out polyaxial screw was removed.Revision surgery 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 backed-out polyaxial screw was removed.Revision surgery took place (b)(6) 2018.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to the manufacturer for evaluation, and a thorough investigation was completed as the lot number has been identified/confirmed in this case.Since the screw remains in the patient, no physical or chemical evaluation could be performed.Post-operative images suggest that the cantilever forces may have overloaded that capture strength of the screws, resulting in the indicating axial slip.
 
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Brand Name
MESA SPINAL SYSTEM
Type of Device
PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M. INC
600 hope parkway se
leesburg, va VA 20175
MDR Report Key7769670
MDR Text Key116646748
Report Number3004774118-2018-00125
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K143334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number6201-095100
Device Lot NumberEYPJ00A
Was Device Available for Evaluation? No
Date Manufacturer Received07/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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