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

Model Number 8801-04014DA

Device Problems Fracture (1260); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Devices remains implanted.

Event Description

It was reported that the locking mechanism of a 3 level ozark cervical plate at c7 separated from the plate post-operatively.Subsequently, the two screws at that level migrated and fractured.Fusion was achieved.Revision surgery has not been scheduled or performed at this time.This report captures the first screw.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.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, and no adverse trends were observed.The reported event of an ozark self-starting variable screw fracture/migration post-operatively was confirmed via communication with the field and x-ray review.Additionally, it was reported via follow up communication that there is no plan to revise the patient as the patient has successfully achieved fusion and has not experienced any pain.The screw holes were prepped with a punch awl, screws inserted with the size 10 tapered driver.Screws were not inserted at a difficult angle and no issues were experienced during securing mechanism locking.Patient was compliant post-op, no trauma/fall was experienced and the patients bone quality is "mediocre".Review of the provided x-ray confirms that the most caudal securing mechanism has disengaged and that the 2 associated screws fractured and/or migrated.X-ray review confirms the patient did fuse successfully, as is expected 8 months post-op.X-ray also reveals that the most caudal cage experienced significant subsidence.Majority of the subsidence observed is of the caudal vertebral body, and minor subsidence observed of the cranial vertebral body.Degree of subsidence is unable to be determined without pre-op and immediate post-op x-rays.If not subsidence, there is a potential that the cage was inserted into a space that was collapsed and disc height was not restored.However, this also cannot be confirmed without pre-op and immediate post-op x-rays.Ozark view and guide surgical technique was reviewed: note: ¿these 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.¿ the most likely cause of the reported event was determined to be due to patient factors.It was reported that the patient has 'mediocre' bone.X-ray review indicates that the most caudal (c6/7) level experienced caudal and minor cranial subsidence.Subsidence can induce excessive stresses on the associated screws and plate which may results in securing mechanism disengagement, screw fracture, and/or screw migration.It is likely that caudal screw angulation may have contributed to the securing disengagement if the caudal screws were angulated similar to cranial screws.However, this cannot be determined conclusively as no immediate post-op / pre-event x-ray received.Additionally, the implants were active for over 8 months and the patient achieved fusion.Implants performed their intended function.

Event Description

It was reported that the locking mechanism of a 3 level ozark cervical plate at c7 separated from the plate post-operatively.Subsequently, the two screws at that level migrated and fractured.Fusion was achieved.Revision surgery has not been scheduled or performed at this time.This report captures the first screw.

• 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: 14523514
• MDR Text Key: 293151671
• Report Number: 3004774118-2022-00214
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• 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: 07/06/2022
• 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 Age: 59 YR
• Patient Sex: Female