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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 801-06540
Device Problem Fracture (1260)
Patient Problem Injury (2348)
Event Date 03/19/2020
Event Type  Injury  
Event Description
It was reported that two mesa polyaxial screws fractured post-operatively.Revision was performed along with an extension.The shafts of both screws remain in the patient as they could not be removed.The surgery was completed with a 30 minute surgical delay.This report represents the second of two screws.
 
Manufacturer Narrative
Visual inspection: the device was inspected.It was observed that the screw shaft was fractured and consistent wear was seen.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Non-union may have contributed to the failure.Per the mesa surgical technique, these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.However, the root cause for the polyaxial screw fracture could not be determined conclusively.
 
Event Description
It was reported that two mesa polyaxial screws fractured post-operatively.Revision was performed along with an extension.The shafts of both screws remain in the patient as they could not be removed.The surgery was completed with a 30 minute surgical delay.This report represents the second of two screws.
 
Event Description
It was reported that two mesa polyaxial screws fractured post-operatively.Revision was performed along with an extension.The shafts of both screws remain in the patient as they could not be removed.The surgery was completed with a 30 minute surgical delay.This report represents the second of two screws.
 
Manufacturer Narrative
D.9 was updated to reflect product return.Visual inspection: the device was inspected.It was observed that the screw shaft was fractured and consistent wear was seen.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Non-union may have contributed to the failure.Per the mesa surgical technique, these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.However, the root cause for the polyaxial screw fracture could not be determined conclusively.
 
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Brand Name
POLYAXIAL SCREW; SIZE 6.5X40 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key9983220
MDR Text Key188413430
Report Number3004774118-2020-00079
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857136113
UDI-Public10888857136113
Combination Product (y/n)N
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number801-06540
Device Catalogue Number801-06540
Device Lot NumberETER07J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2020
Date Manufacturer Received08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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