MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-06535
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that the mesa small stature spinal system deformity polyaxial screw experienced axial slippage of the rod at l5 post-operatively.Revision surgery has not been performed nor scheduled at this time.
Event or Problem Description
It was reported that the mesa small stature spinal system deformity polyaxial screw experienced axial slippage of the rod at l5 post-operatively.Revision surgery has not been performed nor scheduled at this time.
Additional 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.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.Initial surgery was performed on (b)(6) 2021.Per additional correspondence, the issue of axial slippage of the rod at l5 postoperatively was confirmed through x-ray, no complications during the initial surgery were reported.X-rays and surgical notes were not provided.Activity level of the patient and bone quality are unknown.Patient did not experience a fall after initial surgery.Revision surgery has not been performed nor scheduled at this time.The mesa small stature surgical technique and device ifu were reviewed: " potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting.¿ postoperative: ¿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.¿ due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: inadequate initial construct, poor patient bone quality and high activity level of patient.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 12683938
• Report Number: 3004774118-2021-00324
• Device Sequence Number: 19840560
• Product Code: NKB
• UDI-Device Identifier: 10888857046948
• UDI-Public: 10888857046948
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3001-06535
• Device Catalogue Number: 3001-06535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown