MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 2 LEVEL; SIZE 42 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 3914-42F42A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

It was reported that approximately 2 years post-operatively a patient began to experience severe neck pain.Revision surgery was performed where it was discovered that the blue ridge screws and plate locking mechanisms were fractured at c5 and c6.This report will capture the plate.

Manufacturer Narrative

Sections a and d were updated with additionally received patient and device catalog information.

Event Description

It was reported that approximately 2 years post-operatively a patient began to experience severe neck pain.Revision surgery was performed where it was initially reported that the blue ridge screws and plate locking mechanisms were fractured at c5 and c6.Upon further information received from the surgeon, two screws had loosened at c6 and the plate locking mechanisms at c5 and c6 did fracture.No fractures of any screws occurred.This report captures the plate.

Event Description

It was reported that approximately 2 years post-operatively a patient began to experience severe neck pain.Revision surgery was performed where it was initially reported that the blue ridge screws and plate locking mechanisms were fractured at c5 and c6.Upon further information received from the surgeon, two screws had loosened at c6 and the plate locking mechanisms at c5 and c6 did fracture.No fractures of any screws occurred.This report captures the plate.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.X-rays were also not provided.Device history records were not reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Operative notes from the initial procedure were reviewed.An mri from (b)(6) 2018 revealed disk herniation of the right c4-c5 and c5-c6 with significant nerve root compression and spinal cord compression on the right side.The patient also has broad-based disk bulging at c6-c7.The patient underwent a c4-c6 acdf in (b)(6) 2018.Vikos allograft of 7mm was placed at c4-c5.8mm vikos allograft placed at c5-c6.A blue ridge 42 mm 2-level plate was placed from c4-c6 and secured with 12 mm screws.Fluoroscopy was used to confirm proper placement.The patient tolerated the procedure well.In 2019, the patient had follow up x-rays taken.It was reported that these x-rays showed that the plate and screws were all ¿in place¿ with ¿solid osseous fusion within the disc spaces at c4-c6.¿ in (b)(6) 2020, the patient returned to the surgeons office complaining about severe neck and right arm pain.An mri was performed and concluded that the c6-c7 disc was herniated, causing ¿significant spinal cord compression.¿ the patient engages in a job that requires repetitious bending and lifting.Operative notes from the secondary procedure were reviewed.The patient was admitted for an acdf of c6-c7.No device failure from the previous procedure was noted from imaging prior to the second procedure.During the procedure, the c4-c6 plate was identified.It was noted that the c6 clips had fractured and the c6 screws appeared to be loose.A large ridge of bone that had grown adjacent to the plate was removed.The blue ridge plate and all 6 screws were removed.Once removed, it appeared that the plates left c5 screw clip had fractured.It is unknown if the c5 clip was damaged was from screw/plate removal process or was previously damaged.The acdf at c6-c7 was then successfully completed.No surgical delay was reported.The device surgical technique guide (stg) and instructions for use (ifu) was reviewed: -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 a metallic 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.-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 remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.Due to no imaging or products received a definitive root cause could not be determined.However, based on the information provided in the operative notes from both procedures, the most likely cause of the reported event was determined to be multi-factorial.The main contributing factor was determined to most likely be the duration of implantation along with successful fusion.Additionally, degree of patient activity most likely contributed to the event.The device stg and ifu states that this system is designed to maintain alignment until healing occurs.Seventeen month post-op x-ray review reports that successful fusion took place and that the plate and all screws were "in place".Therefore, the implants performed their intended function of facilitating fusion.The stg states that loads produced by load bearing and activity levels will impact the longevity of the implant.The patient reported repetitious bending and lifting associated with their job which most likely contributed to the reported plate securing mechanism fracture and screw loosening.

• Brand Name: CONSTRAINED PLATE, 2 LEVEL; SIZE 42 MM
• Type of Device: 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: 14418315
• MDR Text Key: 291853982
• Report Number: 3004774118-2022-00185
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3914-42F42A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 68 KG