MAUDE Adverse Event Report: K2M, INC. FIXED SCREW, SELF-STARTING; SIZE Ø4.5X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-14514DA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that at 1 month post-op, it was noted that an ozark fixed screw had backed out.It is unknown at this time when revision surgery will take place.
Additional Manufacturer Narrative
B1: has been corrected from "adverse event and product problem" to "product problem".B2: has been has cleared.H1: has been updated from "serious injury" to "malfunction".Visual, dimensional, material, and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The x-ray was reviewed and confirms one of the caudal screws migrated anteriorly.Additionally, it appears that the cranial screws are not completely fixed in bone and may not have optimal purchase.The anchor c cage implanted in the disc space below the ozark plate also appears to be contacting the ozark plate, which may add additional stresses to the entire construct.The more cranial screw of the anchor c implant also appears to be contacting one of the most caudal screws of the ozark plate.This may impede the functionality of the caudal locking mechanism of the ozark plate and/or induce excess stress on the caudal ozark screw.Potential adverse events include, but are not limited to pseudo arthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudo arthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if appropriate), and ruled out preoperatively.The most likely cause of the reported event was improper placement of implants.Lack of bone fixation and contacting implants can add additional stresses to the construct and inhibit the ability of securing mechanism to lock.However, this cannot be confirmed as no immediate post-op x-rays were received and initial implant positioning cannot be established.Therefore the root cause is undetermined.
Event or Problem Description
It was reported that approximately 1 month post-operatively, an ozark fixed screw had backed out.Revision surgery has not been performed nor scheduled at this time.

• Brand Name: FIXED SCREW, SELF-STARTING; SIZE Ø4.5X14 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: 12121316
• Report Number: 3004774118-2021-00202
• Device Sequence Number: 3325015
• Product Code: KWQ
• UDI-Device Identifier: 10888857392687
• UDI-Public: 10888857392687
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 8801-14514DA
• Device Catalogue Number: 8801-14514DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female