MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 3.5X12 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 7601-03512

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Return status of the device/devices is currently unknown.

Event Description

Five yukon set screws migrated post-operatively.The patient will undergo revision surgery in the future.This record captures the third of the five screws.

Manufacturer Narrative

The physician initially reported 5 set screws migrated; however, during revision surgery they found 3 polyaxial screws had migrated and the set screws remained in place.The following fields have been corrected to reflect the updated event information: b.5.Updated from "five yukon set screws migrated post-operatively.Explant surgery has occurred.This record captures the first of the five screws." to "three yukon polyaxial screws migrated post-operatively.Explant surgery has occurred.This record captures the first of three screws." d.1.Updated from "set screw" to "polyaxial screw; size ø3.5x12 mm".D.3.Updated from 'stryker spine- leesburg' to 'k2m, inc.' d.4.Catalog updated from 7601-10001 to 7601-03512.D.4.Lot number updated from unk to gjpj.D.4.Gtin updated from (b)(4).G.1.Updated from 'stryker spine- leesburg' to 'k2m, inc.' visual inspection: the device was inspected, and it was observed that the screw head assembly was fixed at an angle.Abrasions can be observed on the shank threads.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: contraindications.1.The yukon oct spinal system is contraindicated in the presence of infection, pregnancy, metabolic disorders of calcified tissues, grossly distorted anatomy, inadequate tissue coverage, drug/alcohol abuse, mental illness, general neurological conditions, immunosuppressive disorders, patients with known sensitivity to materials in the device, obesity, patients who are unwilling to restrict activities or follow medical device, and any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.2.Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, the use of anticoagulants, etc.All have a negative effect on bony union.Contraindications may be relative or absolute and must be carefully weighed against the patient's entire evaluation.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.According to the rep, the patient vapes on a regular basis.Smoking has been shown to have an adverse effect on bony union.Nonunion can contribute to dynamic motion within the construct, which can result in screw pullout.

Event Description

Three yukon polyaxial screws migrated post-operatively.Explant surgery has occurred.This record captures the third of three screws.

• Brand Name: POLYAXIAL SCREW; SIZE 3.5X12 MM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9131321
• MDR Text Key: 166339628
• Report Number: 3004774118-2019-00106
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (y/n): N
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-03512
• Device Lot Number: GJPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention