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

Model Number	1101-04536F
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10960669
• Report Number: 3004774118-2020-00338
• Device Sequence Number: 3250225
• Product Code: NKB
• UDI-Device Identifier: 10888857015395
• UDI-Public: 10888857015395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 1101-04536F
• Device Catalogue Number: 1101-04536F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Weight: 35