MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE 4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04014DA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.It is unknown if the patient experienced an external trauma post operatively or the activity level of the patient.The surgeon is yet to determine if the patient has fused.Since immediate post-op x-rays were not provided, a comparison between the initial construct and current construct cannot be performed.No additional information was provided.Additional follow up confirmed that there is no plan to revise the patient yet.The surgeon will continue to monitor patient.Device sgt and ifu were reviewed.The following is to assist in identifying and/or ruling out potential root cause(s) of the reported event: "remove all osteophytes from the anterior surfaces of the vertebrae to allow the plate to sit flush against the vertebral bodies.Note: bending at or near the screw holes may damage the integrated alloy locking cover.Therefore, bending should only occur in one direction (lordosis or kyphosis)within the desired bend zone area around each window, pictured below.There may be limited or no-bend zones on the shorter plates.The screws are colored-coded by length and function (fixed versus variable).Fixed screws can be inserted ±2º and variable screws can be inserted ±15º, in any direction relative to the neutral angle of the screw hole.Note: do not over angulate screws beyond their indicated limit, doing so could result in the inability to lock the cover.Note: fixed screws have a laser marked line on the head of the screw.After screw insertion, engage the locking cover by inserting the size10 tapered driver into the screw cover and rotating clockwise 90° so that the cover retains the screw heads.Screws should sit below the screw cover to ensure that the locking cover is adequately engaged note: plate geometry should prevent the locking cover from rotating beyond the intended 90°.Do not rotate the locking cover past the clockwise stop on the plate.An exact cause of the reported event cannot be determined with the available information.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.Postoperative care and the patient¿s ability and willingness to follow instructions are two of the most important aspects of successful healing.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.Loads produced by load bearing and activity levels will impact the longevity of the implant.Implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant re-mains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate post-operative management to avoid refracture.
Event or Problem Description
It was reported that the locking mechanism of an ozark plate at c5 fractured and two ozark screws migrated post-operatively.Revision surgery has not been scheduled or performed at this time.This report captures the first of the two screws.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE 4.0X14 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12698865
• Report Number: 3004774118-2021-00326
• Device Sequence Number: 3855255
• Product Code: KWQ
• UDI-Device Identifier: 10888857393363
• UDI-Public: 10888857393363
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 10/26/2021

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: 8801-04014DA
• Device Catalogue Number: 8801-04014DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1