MAUDE Adverse Event Report: WARSAW ORTHOPEDICS BRYAN CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 6470315

Device Problem Torn Material (3024)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

On (b)(6) 2013: the patient presented with pre-op diagnosis: cervical spondylotic myelopathy.Procedures performed: anterior cervical diskectomy at c5-6 with bilateral wide foraminectomies and decompression of the intraspinal canal.Placement of c5-6 arthroplasty using the bryan disc.Use of intra-operative fluoroscopy.Use of intra-operative spinal cord monitoring.On (b)(6) 2014: the patient presented for an office visit.The patient underwent x-rays of cervical spine and showed a stable construct at c5-c6 with appropriate amount of excursion.There is physiologic 1-2mm of anterolisthesis of c5 on c6.On extension, she does have lordosis.On flexion, she has a relatively straight cervical spine.Impression: she has significant muscle spasm from abnormal biomechanics of the neck.On (b)(6) 2014: the patient presented for an office visit.She is now approx.Almost a year status post c5-c6 arthroplasty for radiculopathy.The patient underwent x-ray of cervical spine and showed a stable construct at c5-c6, does not have significant movement.The c5-c6 joint is noted to be widened with forward flexion.Foraminal views show patent foramen throughout, particularly at c5-c6 on right side.Impression: the patient appears to have facet-medicated pain.On (b)(6) 2014: the patient presented for an office visit.The patient underwent x-ray and notable for some hypermobolity at the arthroplasty level.Impression: the patient is not tolerating her artificial disc.Likely the segment is hypermobile and is the source of her pain.On (b)(6) 2014: the patient presented with pre-op diagnosis: c5-c6 instability/hypermobility with facetogenic neck pain.Procedures underwent: removal of existing c5-c6 prosthetic disk device.Placemet of allograft and autograft within intervertebral biomechanical device at c5-c6 for arthrodesis.Placement of anterior instrumentation consisting of plate and screw construct at c5-c6.The patient was injured when a bryan cervical disc replacement failed, necessitating a revision surgery.A consulting neurosurgeon was of the opinion that the bryan disc had a "laceration defect of the outer bladder (sheath)".

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

X-ray analysis: pre op mri and post op x-rays provided for artificial disc replacement c5-6.Hardware placement appears appropriate and within ifu for the device.Flexion extension x-rays show hyper dynamic motion of the cervical spine with a slight anterolisthesis of c5 and c6 at the level of the artificial disc.This may have contributed to construct failure.Per report a manufacturing defect was questioned, but no part was returned.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRYAN CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5767902
• MDR Text Key: 48712841
• Report Number: 1030489-2016-01968
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2015
• Device Catalogue Number: 6470315
• Device Lot Number: W08H12281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 75