MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 2911-06540

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

Patient Problems Pain (1994); Injury (2348)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The device remains implanted.

Event Description

A physician reported that two everest polyaxial screws implanted as s1 have fractured shafts.The devices remain implanted in the patient and revision surgery is not currently scheduled.The patient has reported experiencing pain.This report captures the second of two screws.

Manufacturer Narrative

D3 and g1: updated from stryker spine-leesburg to k2m, inc.Post-operative x-rays were provided by the rep.Analysis of the x-rays revealed that the subject screws were implanted bilaterally at the most caudal level of the construct, at s1.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 since the device associated with this event was not returned.The everest surgical technique was reviewed and the following relevant information was identified: 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.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.Surgical implants must never be reused.An explanted metal implant should never be reimplanted.Even though the device appears undamaged, it may have small imperfections and internal stress patterns which may lead to early breakage.Analysis of the x-rays revealed that the subject screws were implanted bilaterally at the most caudal level of the construct, at s1.Both screws had fractured approximately mid-shaft.As the screws were not available for evaluation, the root cause could not be determined conclusively.It is possible that failure occurred in fatigue.Screws at the most caudal level of the construct are subjected to more stress.Dynamic motions can compound cantilever forces, resulting in screw fracture.

Event Description

A physician reported that two everest polyaxial screws implanted at s1 have fractured shafts.It was reported the patient was experiencing pain.Revision surgery was performed and a stand alone alif was implanted; however, the screws were not removed.This report captures the second of two screws.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X40 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9180717
• MDR Text Key: 178367032
• Report Number: 3004774118-2019-00122
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857042315
• UDI-Public: 10888857042315
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2911-06540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention