MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK BRYAN CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Device Problems Migration or Expulsion of Device (1395); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported in the literature titled ¿metallosis after traumatic loosening of cervical disc arthroplasty: a case report and literature review¿ that the patient was diagnosed with cervical radiculopathy due to a herniated disc involving c6-c7 (fig.1a, b) and was treated with anterior discectomy with cervical disc replacement with an artificial disc.Post-op , progressive neck pain and bilateral numbness in both hands were noted nearly 1 year later.This symptom deteriorated to numbness in all four limbs and eventually evolved into a gait disturbance.Patient also had metallosis where the mass spectrometry results revealed slight concentrations of titanium-ions in the serum at 20.81 ppb of the patient.Removal of the disc was performed to treat the cervical myeloradiculopathy.Cervical spine radiographs revealed anterior migration of the upper titanium shell of the disc.The flexion/extension view also identified loss of range of motion at the c6¿c7 level.Cervical spine mri revealed a mass lesion along the dorsal aspect of the disc with spinal cord compression.Intraoperative findings- during the revision surgery for disc removal, thick inflammatory soft tissue was found at the prevertebral fascial layer opened for disc exposure, followed by efflux of gray fluid.Metallosis was the preferred diagnosis.An intraspinal metalloma was noted containing abundant brown to black pigment deposition within the soft tissues.

• Brand Name: BRYAN CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7539373
• MDR Text Key: 109100202
• Report Number: 1030489-2018-00736
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 56 YR