MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigation.
Event or Problem Description
This report summarizes one malfunction event where the main body of a yukon oct polyaxial screw broke during insertion.Surgery was successfully completed with a 30-60 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual, material, functional and dimensional analysis could not be performed as the device was not returned.A review of the device history records could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.According to the rep, the surgeon attempted to adjust the screw height with a 'stab-and-grab' driver just prior to rod placement.As the screw was inserted deeper, the screw shank broke just below the tulip.Trephines were used to attempt removal of the screw shank, resulting in extra removal of bone.The remainder of the screw shank could not be removed and was left in the patient.The tulip was not returned and was therefore unavailable for evaluation.The patient reportedly had hard bone.Inserting the screw in harder than normal bone likely compromised the structural integrity of the screw shank, resulting in fracture.H3 other text : device not returned.
Event or Problem Description
This report summarizes one malfunction event where the main body of a yukon oct polyaxial screw broke during insertion.Surgery was successfully completed with a 30-60 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE 4.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12242671
• Report Number: 3004774118-2021-00228
• Device Sequence Number: 17218765
• Product Code: NKG
• UDI-Device Identifier: 10888857349605
• UDI-Public: 10888857349605
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• 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): 10/27/2021

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: 7601-04030
• Device Catalogue Number: 7601-04030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1