MAUDE Adverse Event Report: K2M, INC. SET SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 7601-10001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that a yukon blocker at the top of the construct has migrated post-operatively.Revision will not occur.

Manufacturer Narrative

H5 was corrected from 'no' to 'yes'.Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.It was reported that a yukon oct set screw migrated from the cranial end of a construct post-operatively.The migrated set screw was discovered during a post-operative x-ray performed a couple of months after initial implantation.The set screw is still implanted in the patient, and there is currently no revision surgery scheduled to remove the device.It is unknown if the patient experienced any external trauma following the surgery.It is unknown if the rod was reduced prior to final tightening.Since the device was not returned, and no additional patient information or x-rays were available for review an exact cause of the reported event could not be determined.

Event Description

It was reported that a yukon blocker at the top of the construct has migrated post-operatively.Revision will not occur.

• Brand Name: SET SCREW
• Type of Device: 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: 13639944
• MDR Text Key: 288103242
• Report Number: 3004774118-2022-00072
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7601-10001
• Device Catalogue Number: 7601-10001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1