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

Model Number	7601-10001
Medical Device Problem Codes	Ambient Noise Problem (2877); Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that a patient has been "complaining of squeaky noise in neck" post-operatively.Xray provided shows a loose yukon oct set screw at t2.Revision surgery has not been scheduled at this time.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.X-rays were provided by the rep.Upon review, it was observed that a set screw, implanted at the distal end of the construct, was floating above the screw.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.Per the ifu, these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.It is also possible that the set screw was tightened with insufficient torque or the rod was not fully reduced.Sub-optimal engagement between the set screw and rod may contribute to loosening and eventually migration.Due to a lack of information and the device not being returned, the root cause of the reported event can not be determined.Potential root causes include: user error (unstable construct); incorrect or small-sized screws implanted; poor bone quality of patient; patient experiences a fall or trauma post-surgery; high activity level of patient post-surgery.
Event or Problem Description
It was reported that a patient has been "complaining of squeaky noise in neck" post-operatively.Xray provided shows a loose yukon oct set screw at t2.Revision surgery has not been scheduled at this time.

• Brand Name: SET SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11467554
• Report Number: 3004774118-2021-00070
• Device Sequence Number: 11643430
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 7601-10001
• Device Catalogue Number: 7601-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR