MAUDE Adverse Event Report: K2M, INC. FENESTRATED, POLYAXIAL SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number F2911-06545

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Status and location of the device are currently unknown.

Event Description

During a planned revision surgery on (b)(6) 2019 for a rod reduction, it was discovered via x-ray that an everest polyaxial screw had fractured.

Event Description

During a planned revision surgery on (b)(6) 2019 for a rod reduction, it was discovered via x-ray that an everest polyaxial screw had fractured.Patient had not completely fused.

Manufacturer Narrative

Correction: from "required intervention." to no input.Correction: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual inspection observed that the distal tip of the screw was fractured.The fracture occurs across the fenestrations at the distal end of the threaded shaft.X-rays were reviewed, and it appeared that the left screw at s1 was broken at the distal tip.Material analysis determined there to be material fatigue.The fracture occurs across the fenestrations, so it is possible that minor dynamic stresses were translated to these stress-concentrators, compounding over time and leading to a failure in fatigue.Device and complaint history records were reviewed, no relevant manufacturing or similar complaints were identified.Per surgical technique: patient selection and compliance is extremely important.Based on fatigue testing results, the k2m range spinal system has been determined to be substantially equivalent to predicate devices however, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.Spinal implant surgery on patients with conditions listed under contraindications may not be candidates for this procedure.The patient must be made aware of the limitations of the implant and that physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices.The patient should understand that a metallic implant is not as strong as a normal, healthy bone and will fracture under normal load bearing in the absence of complete bone healing.An active, debilitated or uncooperative patient who cannot properly restrict activities may be at particular risk during postoperative rehabilitation.Potential risks identified with the use of this device system which may require additional surgery include device component failure, loss of fixation, non-union, fracture of the vertebra, and neurological, vascular or visceral injury.Cutting, bending, or scratching the surface of metal components can significantly reduce the strength and resistance of the implant system and should be avoided where possible.These, in turn may cause cracks and/or internal stresses that are not obvious to the eye and may lead to fracture of the components.Especially avoid sharp or reverse bends and notches.Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids and alkalis which can cause corrosion.Putting dissimilar metals (e.G.Titanium and stainless steel) in contact with each other can accelerate the corrosion process which in turn may enhance fatigue fractures of implants.Thus ever effort should be made to use compatible metals and alloys.Fretting or wear at the interface between components of a device may also accelerate the corrosion process and may lead to the generation of wear debris which has been associated with localized inflammatory response.After reviewing the complaint with everest engineers and examining similar incidents, the root cause was determined to be material fatigue.

• Brand Name: FENESTRATED, POLYAXIAL SCREW; SIZE 6.5X45 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9083732
• MDR Text Key: 178210318
• Report Number: 3004774118-2019-00096
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: F2911-06545
• Device Lot Number: GMRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 100