MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X18 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04018DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that two ozark self-starting variable screws at c6 fractured and the securing mechanism of an ozark two-level plate fractured.The patient has been revised.This report captures the first of two ozark self-tapping screw.
Event or Problem Description
A physician reported that two ozark self-starting variable screws at c6 fractured and the securing mechanism of an ozark two-level plate fractured.The patient has been revised.This report captures the first of two ozark self-tapping screw.
Additional Manufacturer Narrative
Visual inspection confirms screw fracture.Screw fractured approximately at the midpoint of screw shaft.Witness mark is observed on the outer edge of the largest cross section of the screw head.Witness mark observed on screw head indicates that the screw was most likely over angulated and/or not fully seated in plate during securing mechanism locking.Additionally, witness marks observed on the posterior side of the disengaged plate securing mechanism indicates screw over angulation and/or screws not being fully seated in plate during securing mechanism locking.Complaint history was reviewed and no similar complaints for the reported lot number were identified.X-rays provided confirm caudal screw fractures.No significant subsidence is observed.The patient's spine is very degenerated and it is difficult to determine the level of fusion due to low quality of images provided.From the ozark view and guide surgical technique: 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 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.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.The patient must be made aware of the limitations of the implant and that physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices.The patient should understand that an implant is not as strong as a normal, healthy bone and will fracture under normal load bearing in the absence of complete bone healing.An active, debilitated or uncooperative patient who cannot properly restrict activities may be at particular risk during postoperative rehabilitation.Adequately instruct the patient.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.Based on the visual inspection of screws and plate, the most likely cause of the reported event was determined to be screw over angulation and/or not being fully seated in plate during securing mechanism locking.Screw over angulation and/or not being fully seated in plate can potentially apply higher than intended forces on the plate securing mechanism which can potentially cause securing mechanism disengagement.Securing mechanism disengagement can result in screw migration and or fracture, as the construct integrity is compromised.Additionally, pseudarthrosis and/or other patient factors may have contribute to screw fracture, but cannot be confirmed due to low quality of x-rays.
Event or Problem Description
A physician reported that two ozark self-starting variable screws at c6 fractured and the securing mechanism of an ozark two-level plate fractured.The patient has been revised.This report captures the first of two ozark self-tapping screw.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X18 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: 13399727
• Report Number: 3004774118-2022-00038
• Device Sequence Number: 4950736
• Product Code: KWQ
• UDI-Device Identifier: 10888857393400
• UDI-Public: 10888857393400
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 8801-04018DA
• Device Catalogue Number: 8801-04018DA
• Device Lot Number: MYHT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 04/29/2022
• 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 Sex: Female