MAUDE Adverse Event Report: K2M, INC. FIXED SCREW, SELF-STARTING; SIZE Ø4.0X12 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-14012DA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient presented with pain and difficulty swallowing approximately 9-months post-operatively.A subsequent x-ray revealed that an ozark screw at c7 had backed out of an ozark plate.The patient was revised and a pcf was performed.This report captured the ozark screw.
Event or Problem Description
A patient presented with pain and difficulty swallowing approximately 9-months post-operatively.A subsequent x-ray revealed that an ozark screw at c7 had backed out of an ozark plate.The patient was revised and a pcf was performed.This report captured the ozark screw.
Additional Manufacturer Narrative
Visual inspection was performed.The screw head and threads have wear marks.Complaint history records were reviewed for this lot, no similar complaints were identified.It was reported that this event was noticed 9 months post-op due to the patient experiencing neck pain and difficulty swallowing.A drill guide and tap were not used during the initial procedure.The fixed screws were reported to be inserted at a relatively steep angle.The patient had soft bone and did not experience any trauma or accident.The most likely cause of the reported event was determined to be due to the over angulation of screws during the locking of the securing mechanism.Once the securing mechanism is damaged, it can no longer perform its intended function of retaining screws.Securing mechanism deformation, plate wear, and screw witness marks all indicate screws were most likely over angulated.It was reported that that "fixed screws were inserted at a relatively steep angle." stg states, "screws should sit below the screw cover to ensure that the locking cover is adequately engaged.Do not over angulate screws beyond their indicated limit, doing so could result in the inability to lock the cover.".

• Brand Name: FIXED SCREW, SELF-STARTING; SIZE Ø4.0X12 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 12749145
• Report Number: 3004774118-2021-00347
• Device Sequence Number: 4012467
• Product Code: KWQ
• UDI-Device Identifier: 10888857392328
• UDI-Public: 10888857392328
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8801-14012DA
• Device Catalogue Number: 8801-14012DA
• Device Lot Number: KURX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown