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)
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 was 'complaining of squeaky noise in neck' post-operatively.No further information has been provided at this time.The nature of the reported noise is unknown at this time and no relationship to the devices has been established.
Additional Manufacturer Narrative
A.2.Has been populated with patient age.
Event or Problem Description
It was reported that a patient was 'complaining of squeaky noise in neck' post-operatively.No further information has been provided at this time.The nature of the reported noise is unknown at this time and no relationship to the devices has been established.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history record review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no similar complaints were identified.No devices or x-rays were available for evaluation.Previous similar incidents suggest that the set screw may have migrated.However, this potential failure mode could not be properly evaluated, and the root cause of the issue was unable to be determined.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.
Event or Problem Description
It was reported that a patient was 'complaining of squeaky noise in neck' post-operatively.No further information has been provided at this time.The nature of the reported noise is unknown at this time and no relationship to the devices has been established.
Event or Problem Description
It was reported that a patient was 'complaining of squeaky noise in neck' post-operatively.No further information has been provided at this time.The nature of the reported noise is unknown at this time and no relationship to the devices has been established.
Additional Manufacturer Narrative
Section a.Patient data was previously reported as '(b)(6)'; however the patient information for this report is unknown.

• 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: 11467520
• Report Number: 3004774118-2021-00071
• Device Sequence Number: 19713482
• 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,Followup,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: 02/11/2021; 05/31/2021; 05/31/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/12/2021; 06/29/2021; 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