MAUDE Adverse Event Report: K2M, INC. PLATE, 5 LEVEL; SIZE 100 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-45F100V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent revision surgery to address two migrated ozark self-starting variable screws at t1 and an ozark five-level plate with a disengaged securing mechanism at levels c3 and t1.This report captures the ozark five-level plate.
Additional Manufacturer Narrative
Visual inspection was performed and confirms both the cranial and caudal end securing mechanisms are disengaged.It could not be confirmed which end was which.The posterior side of disengaged securing mechanisms exhibit deformation on the edges.Deformation observed on bottom of both securing mechanisms indicates cranial and caudal screws were most likely over angulated and/or not completely seated in plate during securing mechanism locking.This deformation is not observed on the other four securing mechanisms (located in the middle of the plate).Additionally, witness marks are observed on the heads of four of the twelve returned screws.Witness marks on the two disengaged securing mechanisms and four of the twelve returned screws indicates that these four screws were most likely the cranial and caudal pairs of screws.Wear is observed on edges of the cranial and caudal screw holes which may indicate screw over angulation during insertion.Complaint history was reviewed and no similar complaints for the reported lot number were identified.Initial report states ozark screw migration and securing mechanism broke on levels c3 and t1.Implants were removed during revision surgery.Upon follow up it is reported that both t1 screws migrated and the caudal plate securing mechanism disengaged post-op.The cranial securing mechanism (c3 level) disengaged while unlocking during the revision surgery for plate and screw removal.It was reported that implants were placed approximately 6 months prior to revision.Fusion was achieved on all levels except the most caudal level.The bottom level was close to fusing so the surgeon decided to leave the cage and let the patient heal.Ozark surgical technique was reviewed and the following relevant information was identified: 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.After screw insertion, engage the locking cover by inserting the size 10 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.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.The most likely cause of the reported event was determined to be the over angulation of cranial and caudal screws which may exert excess strain and stress on the securing mechanisms.

• Brand Name: PLATE, 5 LEVEL; SIZE 100 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: 13978629
• Report Number: 3004774118-2022-00126
• Device Sequence Number: 5994593
• Product Code: KWQ
• UDI-Device Identifier: 10888857402836
• UDI-Public: 10888857402836
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: AA01-45F100V
• Device Catalogue Number: AA01-45F100V
• Device Lot Number: NDEE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 59 YR
• Patient Sex: Male