MAUDE Adverse Event Report: K2M, INC. EVEREST SET SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Autoimmune Reaction (1733); Pain (1994); Hernia (2240); Constipation (3274)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing; a supplemental report will be sent upon receipt of any additional information.Device remains implanted.

Event Description

A patient reported (mw5090760) they were implanted with everest rods, everest screws, and everest set screws at l4 to s1 to treat grade 1 spondylisthesis.Prior to implantation the patient experienced pain in low back, right hip, and down both legs.Following implantation, the patient reported numerous issues including: gi conditions (constipation), hiatal hernia, immunological conditions, seronegative arthritis, spondyloarthropathy, and pain in low back, mid back, upper back, sacrum, glutes, pelvis, hips, feet, legs.The devices remain implanted.

Manufacturer Narrative

No devices or radiological images were available for evaluation.Due to insufficient information, we were unable to attribute the patient's conditions to device failure.According to the everest product insert, potential adverse events associated with spinal fusion procedures include neurologic damage (usually attributable to pseudoarthrosis), infections, painful bursa, pressure necrosis, allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.In september 2019, the fda published a paper entitled "biological responses to metal implants." upon review by a physician, even if serological tests show elevated metallic ions, there is no clear evidence that increased levels are necessarily associated with clinical symptoms.We were unable to determine the root cause.No device failure mode could be identified for the reported event; therefore, a risk assessment could not be performed.We were unable to perform a manufacturing record review as subject lot numbers were not provided.A review of complaint history could not be performed as subject catalog numbers were not available.No further investigation for this event is possible at this time as no device and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.

Event Description

A patient reported (mw5090760) they were implanted with everest rods, everest screws, and everest set screws at l4 to s1 to treat grade 1 spondylisthesis.Prior to implantation the patient experienced pain in low back, right hip, and down both legs.Following implantation, the patient reported numerous issues including: gi conditions (constipation), hiatal hernia, immunological conditions, seronegative arthritis, spondyloarthropathy, and pain in low back, mid back, upper back, sacrum, glutes, pelvis, hips, feet, legs.The devices remain implanted.

• Brand Name: EVEREST SET SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9497310
• MDR Text Key: 188138756
• Report Number: 3004774118-2019-00167
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other