MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 8801-04014DA

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

Devices remains implanted.

Event Description

A patient reported that they were experiencing pain approximately five months post-operatively.Imaging was performed and the physician reported that four ozark cervical screws had fractured and the ozark cervical plate securing mechanism had disengaged at c3.The physician indicates that the patient appears to have achieved fusion and revision surgery has not been scheduled or performed.This report captures the third of four ozark cervical screws.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.However, a post-event x-ray was provided which confirms that all 4 screws of the level 1 acdf fractured.Additionally, the caudal securing mechanism disengaged.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, similar complaints were identified.It was reported via follow-up communication that no immediate post-op x-rays are available for review.There is no plan to revise the patient at this time although they have experienced some pain.The screw holes were prepped with the 14 mm variable drill guide.The screws were inserted using the non-tapered driver and blue handle.The screws were not inserted at a difficult angle and there was no difficulty locking the securing mechanism.The patient had good bone quality, was compliant post-op, and did not experience any fall/trauma.The surgeon felt that the patient achieved fusion.The device surgical technique guide was reviewed: "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.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".Due to the devices remaining implanted and no immediate post-op x-ray available, a definitive root cause could not be determined.Potential causes of fracture include, but are not limited to patient anatomical factors, patient non-compliance, patient accident/trauma, and/or normal mechanical limitations of the implant(s).As stated in stg, internal fixation devices are load sharing devices which maintain alignment until healing occurs.If an implant re-mains implanted after complete healing, it can actually increase the risk of refracture in an active individual.It was reported the patient achieved fusion, indicating the screws performed their intended function.

Event Description

A patient reported that they were experiencing pain approximately five months post-operatively.Imaging was performed and the physician reported that four ozark cervical screws had fractured and the ozark cervical plate securing mechanism had disengaged at c3.The physician indicates that the patient appears to have achieved fusion and revision surgery has not been scheduled or performed.This report captures the third of four ozark cervical screws.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 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: 14745866
• MDR Text Key: 295317125
• Report Number: 3004774118-2022-00244
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857393363
• UDI-Public: 10888857393363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8801-04014DA
• Device Catalogue Number: 8801-04014DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• 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): Other
• Patient Sex: Male