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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 801-05540
Device Problem Device Slipped (1584)
Patient Problems Injury (2348); No Information (3190)
Event Date 10/31/2018
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 yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On 11.01.2018 it was reported to k2m, inc.That a revision took place approximately 24 months post-operatively due to rod slippage.Patient was revised on (b)(6) 2018.
 
Manufacturer Narrative
It was reported that a mesa polyaxial screw was fractured approximately two years post-operatively, while several other mesa pedicle screws reportedly slipped axially along a rod.The screws were returned, visually and microscopically inspected.The fractured screw was confirmed during this analysis.The fracture face exhibited beach marks, consistent with failure in fatigue.The remaining screws exhibited signs of use, but otherwise no other discrepancies were visible.Post-operative x-rays were not available for review, so the axial slip could not be confirmed, nor could a root cause be determined.These devices are intended to be an adjunct to spinal fusion.It could not be determined if fusion was achieved.Incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, which may contribute to a failure of this nature.Additionally, it was reported that the patient may have been participating in moderately strenuous activity, which could also have introduced unanticipated loading within to the construct, leading to the axial slip along the rod.All available manufacturing an inspection records were reviewed for the subject lots, and no relevant discrepancies were discovered.Corrections: from: on (b)(6) 2018 it was reported to k2m, inc.That a revision took place approximately 24 months post operatively due to rod slippage.The shaft of the broken screw was left implanted.Patient was revised on (b)(6) 2018.To: on (b)(6) 2018 it was reported to k2m, inc.That a revision took place approximately 24 months post operatively due to rod slippage and screw fracture.Patient was revised on (b)(6) 2018.(related to 3004774118-2018-00171, 3004774118-2018-00177, and 3004774118-2018-00178) from 801-05540d lot dfky to 801-05540d-sg lot dfky.
 
Event Description
On 11.01.2018 it was reported to k2m, inc.That a revision took place approximately 24 months post operatively due to rod slippage and screw fracture.Patient was revised on (b)(6) 2018.(related to 3004774118-2018-00171, 3004774118-2018-00177, and 3004774118-2018-00178).
 
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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
MDR Report Key8115031
MDR Text Key128739341
Report Number3004774118-2018-00179
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number801-05540
Device Lot NumberEMDR
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
801-05540D LOT DFKY; 801-05540D-SG LOT DFKY; 801-06540 LOT EMEBQ1Y; 801-06540 LOT EMEBQ1Y; 801-36540 LOT EBRA092, EBRA09W; 801-36540 LOT EBRA092, EBRA09W; 801-36540 LOT EFRJ06X; 801-36540 LOT EFRJ06X; 801-05540D LOT DFKY; 801-06540 LOT EMEBQ1Y; 801-36540 LOT EBRA092, EBRA09W; 801-36540 LOT EFRJ06X
Patient Outcome(s) Required Intervention;
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