MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05024
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during intra-operative screw insertion into the t1 pedicle a yukon polyaxial screw tulip disengaged from the screw shaft.The screw shaft could not be removed and remains at that level.There were no adverse consequences to the patient.The procedure was completed successfully with a 5-10 minute surgical delay by bypassing that level and proceeding on with the construct.
Additional Manufacturer Narrative
Updated to reflect the screw fractured at the shaft.(device code grid has been updated from 'material separation' to 'fracture'.Upon visual inspection it was observed that the fracture occurred on the shank, immediately below the ball feature.The fracture surface is smooth.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.Additional information was received upon correspondence with rep.It was stated that the patient had hard bone, and the resistance increased as the screw was driven in.The bone was prepped as intended using a drill and 4.0mm tap.The angle of insertion was not reported to be difficult.From the information provided, it is likely that the implant fractured due to patient factors.Inserting a screw into harder than normal bone can place compound forces at the shaft, which can lead to fracture.
Event or Problem Description
It was reported that during intra-operative screw insertion into the t1 pedicle a yukon polyaxial screw fractured at the shaft.The screw shaft could not be removed and remains at that level.There were no adverse consequences to the patient.The procedure was completed successfully with a 5-10 minute surgical delay by bypassing that level and proceeding on with the construct.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X24 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10574761
• Report Number: 3004774118-2020-00219
• Device Sequence Number: 16927623
• Product Code: NKG
• UDI-Device Identifier: 10888857349995
• UDI-Public: 10888857349995
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-05024
• Device Catalogue Number: 7601-05024
• Device Lot Number: JKDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other