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

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported by tian et al that : cervical artificial disc replacement was performed in 164 cases from (b)(6) 2003 to (b)(6) 2007, and all the cases were retrospectively followed up.Among them, 1 disc replacement was done in 132 cases, 2 discs in 28 cases and 3 discs in 4 cases with a total number of (b)(4) artificial discs.There were 102 male patients and 62 female patients.Their age ranged from 25 to 70 years old (with an average of (b)(6)).All the cases were operated according to the standard procedure for cervical artificial disc replacement, and immobilized in a cervical collar for 2 weeks after operation.Motion of the replaced disc in sagittal direction, joa score and satisfaction rate of the patients were followed up and evaluated.In this group, no acute complications happened during the operation.Loosening of the prosthesis happened in 1 case 6 months after operation but remained stable afterwards.

Manufacturer Narrative

Additional info.Literature article citation: tian et al.¿functional evaluation of the cervical spine after bryan artificial disc replacement¿ zhonghua wai ke za zhi.2008 mar 1;46(5):333-7.Mean age 47 years (range 25 to 70).Patient: 102 male patients and 62 female patients.(b)(4).Neither device nor applicable imaging studies received for evaluation.

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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4861184
• MDR Text Key: 5848631
• Report Number: 1030489-2015-01266
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2015
• 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): Other
• Patient Age: 00047 YR