MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
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 kxnd.One (1) device has been captured under lot jdaa.The lot number is unknown for one (1) device.Two (2) of the three (3) 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 three malfunction events where yukon oct polyaxial screws fractured intra-operatively.Surgery was successfully completed and no adverse consequences or medical intervention were reported.
Event or Problem Description
This report summarizes three malfunction events where yukon oct polyaxial screws fractured intra-operatively.Surgery was successfully completed and 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 the two returned devices, it was observed that the screws had fractured immediately below the ball feature of the screw shank.Analysis of the fracture indicated that the failure likely occurred in torsion.According to the rep, the patient had sclerotic bone.Inserting screws in harder than normal bone can compound torsional forces at the shaft, resulting in a failure of this nature.The screw shafts were left in the patient, and the surgery was completed.One device was not returned.It is possible that excessive torsional forces compromised the structural integrity of the screw shank.However, as the device was not returned for evaluation, the root cause could not be determined conclusively.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11247964
• Report Number: 3004774118-2021-00020
• Device Sequence Number: 3649008
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 3
• 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: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: KXND, JDAA
• 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