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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 6201-06545
Device Problems Crack (1135); Fracture (1260); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  Injury  
Event Description
It was reported that post-operatively on x-ray, the mesa 2 deformity polyaxial screw head was noted to be damaged laterally. Revision surgery was performed where the implant was explanted.
 
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Brand NameMESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X45 MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key12037302
MDR Text Key257473231
Report Number3004774118-2021-00183
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857164550
UDI-Public10888857164550
Combination Product (y/n)N
PMA/PMN Number
K143334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6201-06545
Device Catalogue Number6201-06545
Device Lot NumberKPHA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/21/2021 Patient Sequence Number: 1
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