MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Pain (1994); Scar Tissue (2060); Impaired Healing (2378)

Event Date 02/09/2015

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: lee, w.T., liu, g., thambiah, j., wong, h.K.(2015).Clinical outcomes of single level lumbar artificial disc replacement compared with transforaminal lumbar interbody fusion in an asian population.Singapore medical journal, p1-14.Singapore.This was a review of hospital records for synthes prodisc-l surgeries or transforaminal lumbar interbody fusion (tlif) between 2002 and 2007.The purpose of the study was to examine the clinical outcome of single level artificial disc replacement (adr) compared to tlif for the treatment of symptomatic degenerative disc disease (ddd) in asian population.The study population included: a total of 74 patients with 54 (41 males, 13 females) in adr group.Adr group ages ranged 21-55 years old with mean of 34.Surgery levels with adr group were l4/5 (n=21) and l5s1 (n=33).Follow up visits were at 2 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively.Only 38 were included in adr group with 2 year follow-up minimum.Surgical complications were not specified by surgery and therefore will be reported.Complications for prodisc-l: adr 3 ¿ pain free for 6 months, adjacent level pain and revised tlif at l5/s1 and l4/5 posterior decompression at implant level, pain free at last follow-up, facet joint osteoarthritis and scar tissue at l4/5 implant level.[mri].This is report #12 of15 for (b)(4).This report is for an unknown prodisc-l polyethylene inlay with an unknown part number, lot number and quantity.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Literature citation: lee, w.T., liu, g., thambiah, j., wong, h.K.(2015).Clinical outcomes of single level lumbar artificial disc replacement compared with transforaminal lumbar interbody fusion in an asian population.Singapore medical journal, p1-14.This report is for an unknown prodisc-l polyethylene inlay with unknown part and lot numbers.(b)(6).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4787065
• MDR Text Key: 5801604
• Report Number: 2530088-2015-10425
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PP050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention