MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.5X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: one (1) device has been captured under lot kcmu.One (1) device has been captured under lot jtyt.Both devices have been returned and are pending evaluation.A supplemental vmsr will be submitted upon completion of investigation.
Event or Problem Description
This report summarizes two malfunction events where yukon oct polyaxial screws fractured intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
This report summarizes two malfunction events where yukon oct polyaxial screws fractured intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Upon review of lot kcmu, it was determined that a fracture did not occur as reported.The device was inspected, and it was observed that the screw housing had disassembled from the screw shank.It was also observed that the screw hexalobe feature was significantly deformed.Upon review of lot jtyt, it was observed that screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face indicated that the failure likely occurred in torsion.Excessive torsional forces during insertion may have overloaded the structural integrity of the screw, resulting in a failure of this nature.Inserting the screw in harder than normal bone may have also contributed to the failure.

• Brand Name: POLYAXIAL SCREW; SIZE 4.5X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11247991
• Report Number: 3004774118-2021-00021
• Device Sequence Number: 3649009
• Product Code: NKG
• UDI-Device Identifier: 10888857349810
• UDI-Public: 10888857349810
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-04530
• Device Catalogue Number: 7601-04530
• Device Lot Number: KCMU, JTYT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 01/01/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1