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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM
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K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 801-06545
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/26/2017
Event Type  malfunction  
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) 2017 it was reported to k2m, inc.That a patient presented with a screw break.The patient reportedly had a screw break approximately 25 months post-op.There are no plans to revise at this time.The patient is asymptomatic.
 
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 screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Our instructions for use indicate that these implants are not indicated for permanent fixation.They are intended to facilitate arthrodesis of the spine, which was achieved prior to the screw breaking.Although fusion was reported at the l5/s1 level, adjacent "non-fusion" at l4/l5 could contribute to dynamic stresses in the construct.
 
Event Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a screw break.The patient reportedly had a screw break approximately 25 months post-op.There are no plans to revise at this time.The patient is asymptomatic.
 
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Brand Name
MESA SPINAL SYSTEM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
sandra gilbert
600 hope parkway se
leesburg, VA 20175
5719195195
MDR Report Key6821250
MDR Text Key83695307
Report Number3004774118-2017-00106
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number801-06545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/26/2017
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
Patient Age65 YR
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