MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X34 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05034
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yukon oct polyaxial screw tulip disengaged intra-operatively.During screw insertion, the screw head kept spinning and the screw would not advance.There were no adverse consequences to the patient.The procedure was completed successfully, with a 15 minute surgical delay, by replacing the screw.
Event or Problem Description
It was reported that a yukon oct polyaxial screw tulip disengaged intra-operatively.During screw insertion, the screw head kept spinning and the screw would not advance.There were no adverse consequences to the patient.The procedure was completed successfully, with a 15 minute surgical delay, by replacing the screw.
Additional Manufacturer Narrative
Visual inspection: 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, suggesting excessive torsional load.Complaint history records were reviewed for this lot, and no similar complaints were identified.We were unable to confirm the root cause but, it is possible that over-angulation of the screw, coupled with excessive torsional load, overloaded the screw housing assembly.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X34 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10818086
• Report Number: 3004774118-2020-00299
• Device Sequence Number: 16619867
• Product Code: NKG
• UDI-Device Identifier: 10888857350045
• UDI-Public: 10888857350045
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 7601-05034
• Device Catalogue Number: 7601-05034
• Device Lot Number: JWUX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1