MAUDE Adverse Event Report: K2M, INC. AXIAL CONNECTOR; SIZE 20 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 3001-84520HV

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Injury (2348)

Event Date 08/05/2019

Event Type  Injury  

Event Description

A mesa rail small stature axial connector was noted to have loosened post-operatively causing the rail to which it was attached to migrate.Patient underwent revision surgery.

Manufacturer Narrative

Mfr name, city & state corrected from stryker spine-us to k2m, inc and mfr site corrected from stryker spine- leesburg to k2m, inc.Dimensional, functional, and material analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The rail slippage from the mesa rail small stature axial connector was recognized after analyzing an x-ray three days post-operatively.The mesa rail small stature surgical technique was reviewed and the following relevant information was identified: 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, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out pre-operatively.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 the root cause could not be determined conclusively.It is possible that the lack of pedicle screws at multiple fixation segments contributed to dynamic motion within the construct, resulting in rail slippage.

Event Description

A mesa rail small stature axial connector was noted to have loosened post-operatively causing the rail to which it was attached to migrate.Patient underwent revision surgery.

• Brand Name: AXIAL CONNECTOR; SIZE 20 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8959942
• MDR Text Key: 156492804
• Report Number: 3004774118-2019-00086
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3001-84520HV
• Device Lot Number: 1234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50