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

Model Number 2901-10001-SG

Device Problem Migration (4003)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is currently unknown.

Event Description

It was discovered via x-ray, that an everest atr set screw had migrated causing a rod to move from its original position on the posterior spine.Additionally, a vertebral body replacement on the anterior spine dislocated.Revision surgery was performed.This report represents the everest set screw.

Manufacturer Narrative

D.4.Lot has been corrected from 'jwmt-296301' to 'jwmt' visual inspection: the device was inspected, and it was observed that the underside of the set screw exhibited significant radial deformation.Functional inspection: the set screw was able to mate properly with a sample everest screw.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per everest degenerative surgical technique: potential adverse events 1.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 preoperatively.2.Potential risks also include those associated with any spinal surgery resulting in neurological, cardiovascular, respiratory, gastrointestinal or reproductive compromise, or death.Postoperative: 1.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.2.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.3.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.4.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.5.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 (p.38-39).Upon review of the part, it was observed that the underside of the set screw exhibited significant radial deformation, suggesting the rod was not fully reduced prior to final tightening.If a set screw is final tightened while the rod is not fully reduced in the screw head, it could compromise the integrity of the capture mechanism at that level.Post-operative patient activities may have also contributed to the failure.

Event Description

It was discovered via x-ray, that an everest atr set screw had migrated causing a rod to move from its original position on the posterior spine.Additionally, a vertebral body replacement on the anterior spine dislocated.Revision surgery was performed.This report represents the everest set screw.

• Brand Name: SET SCREW; ATR
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10364913
• MDR Text Key: 201706900
• Report Number: 3004774118-2020-00164
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857037946
• UDI-Public: 10888857037946
• Combination Product (y/n): N
• PMA/PMN Number: K161369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2901-10001-SG
• Device Catalogue Number: 2901-10001-SG
• Device Lot Number: JWMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 72