MAUDE Adverse Event Report: K2M, INC. MESAMINI 90 SCREW; SIZE 3.5X16 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1101-03516F
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a mesa mini screw placed at c5 on the right side which had, "come loose from the patient's bone.".
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a mesa mini screw placed at c5 on the right side which had, "come loose from the patient's bone.".
Additional Manufacturer Narrative
Corrected data: changed b.2 from no selection to required intervention to prevent permanent impairment/damage (device).Changed d.10 from 'return' to 'no.'.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: 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.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.Implant removal should be followed by adequate postoperative management to avoid refracture.Non-union may have contributed to the failure.Spinal implants are intended to provide temporary stabilization and facilitate spinal fusion.Incidence of pseudoarthrosis could allow for dynamic motion within the construct, causing the implant to loosen from the bone.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a mesa mini screw placed at c5 on the right side which had, "come loose from the patient's bone.".

• Brand Name: MESAMINI 90 SCREW; SIZE 3.5X16 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9403434
• Report Number: 3004774118-2019-00158
• Device Sequence Number: 2230582
• Product Code: NKG
• UDI-Device Identifier: 10888857012455
• UDI-Public: 10888857012455
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2020

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: 1101-03516F
• Device Catalogue Number: 1101-03516F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 01/26/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/02/2020; 02/24/2020
• 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: 76 YR