MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø4.5X40 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two yukon oct spinal system polyaxial screws heads broke off intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of the two screws.
Event or Problem Description
It was reported that two yukon oct spinal system polyaxial screws heads broke off intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of the two screws.
Additional Manufacturer Narrative
Device analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog was performed, no adverse trends were observed.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: POLYAXIAL SCREW; SIZE Ø4.5X40 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14713776
• Report Number: 3004774118-2022-00240
• Device Sequence Number: 14019465
• Product Code: NKG
• UDI-Device Identifier: 10888857349865
• UDI-Public: 10888857349865
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 7601-04540
• Device Catalogue Number: 7601-04540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG