MAUDE Adverse Event Report: K2M, INC. MESAMINI 90 SCREW; SIZE 4.5X36 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 1101-04536F

Device Problem Fracture (1260)

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

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Device discarded by hospital.

Event Description

It was reported that two mesa mini polyaxial screws fractured at the shank approximately 1 year and 3 months post-operatively.The screws were removed and replaced and the construct was extended to achieve further fusion.This report captures the second of two screws.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed for this lot as a valid lot could not be obtained because the device was discarded by the hospital.The mesa mini surgical technique was reviewed, and the following relevant information was identified: "the primary goal of this surgery is to arthrodese selected vertebrae.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.Metallic 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.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant".The patient was reported to be an active young child with good bone quality.Since the patient had fused, the implants served their purpose.Potential causes of reported event include: overload on implant with time, high activity level by patient.However, an exact cause could not be determined.

Event Description

It was reported that two mesa mini polyaxial screws fractured at the shank approximately 1 year and 3 months post-operatively.The patient had achieved fusion.The screws were removed and replaced and the construct was extended to achieve further fusion.This report captures the second of two screws.

• Brand Name: MESAMINI 90 SCREW; SIZE 4.5X36 MM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10960669
• MDR Text Key: 219994647
• Report Number: 3004774118-2020-00338
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857015395
• UDI-Public: 10888857015395
• Combination Product (y/n): N
• PMA/PMN Number: K153370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1101-04536F
• Device Catalogue Number: 1101-04536F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 35