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

Catalog Number 7601-10001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported that a patient who was implanted with yukon hardware could hear an audible noise coming from the implant site post-operatively.At this time it is unknown if the hardware experienced any failures, which piece of hardware was making noise, or if revision surgery is planned.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned because it remains implanted in the patient.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, no adverse trends were identified.Per additional correspondence, the initial surgery was performed in fall of 2021.The patient is not experiencing any adverse consequences apart from the audible noise.They did not experience any external trauma/ fall after the surgery.The activity levels of the patient are unknown.The bone quality of the patient was reported to be normal and it is unknown if they fused.Operative notes from the initial surgery are not available, but the construct spanned from c3-t1.It is unknown how the bone was prepped, the rod was reduced completely, and there was adequate rod length overhanging from the screw head.The set screw was final tightened to 3.4 nm using a mesa torque limiting handle.It is possible the set screw was not adequately tightened as final tightening was done using a mesa set.However, since the device is not available and no issues with the blocker/ construct have been reported, a failure mode was not identified and hence a root cause of the audible noise cannot be determined.

Event Description

It was reported that a patient who was implanted with yukon hardware could hear an audible noise coming from the implant site post-operatively.At this time it is unknown if the hardware experienced any failures, which piece of hardware was making noise, or if revision surgery is planned.Additional information received from the surgeon on 5/2/2022 has indicated that 'everything looks normal' and the set screw has not migrated.There are no alleged failures with the yukon hardware.

• 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: 13552949
• MDR Text Key: 286511330
• Report Number: 3004774118-2022-00066
• Device Sequence Number: 1
• Product Code: NKG
• 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: 05/25/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 7601-10001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/25/2022
• 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