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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-86055MF
Device Problems Mechanical Jam (2983); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2020
Event Type  malfunction  
Event Description
A company representative reported that the set screw would not thread into two everest axial rod-to-rod connectors during product inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report captures the first of the two devices.
 
Manufacturer Narrative
The device was inspected and no visual non-conformance was observed.Functional inspection was performed the connectors failed the functional test on the closed end but passed on the open end, when tested with a set screw.A ct scan of the part in question showed a slight offset of the minor and major diameter which would lead to having a binding thread.As reported, a patient was not involved and the event resulted in no adverse consequences reported.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history was reviewed and one similar complaint for this lot was identified.A non-conformance was initiated to investigate the root cause of this failure mode.Analysis of the device concluded that the set screw would never fit on the thread of any connector with this non-conforming condition.Therefore, this would always be detected by the user prior to locking of the rod to rod connector.Additional inspection of similar devices indicates this to be an event isolated to the devices captured in this event.
 
Event Description
A company representative reported that the set screw would not thread into two everest axial rod-to-rod connectors during product inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report captures the first of the two devices.
 
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Brand Name
AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10404891
MDR Text Key203128373
Report Number3004774118-2020-00183
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857039728
UDI-Public10888857039728
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 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2901-86055MF
Device Catalogue Number2901-86055MF
Device Lot NumberEJVX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Date Manufacturer Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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