MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Garcia, r., et al (2015).Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activl multicenter randomized controlled ide clinical trial.Spine.40(24), pp 1873-1881.This report is for an unknown pro-disc l polyethylene inlay/unknown lot/quantity unknown.(other number) udi: unknown part number, udi is unavailable.(b)(4).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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after subsequent review of the following journal article garcia, r., et al (2015).Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activl multicenter randomized controlled ide clinical trial.Spine.40(24), pp 1873-1881.The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (tdr) in the treatment of patients with symptomatic degenerative disc disease (ddd) who are unresponsive to nonsurgical therapy.Patients presenting with symptomatic single-level lumbar ddd who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational tdr device (activl, n=218) or fda-approved control tdr devices (synthes prodisc-l or charite, n=106).A total of 324 patients (218 activl, 106 control) were randomized at 14 sites between january 2007 and december 2009.Of the 106 controls, 64 received the prodisc-l.Two cases of subsidence and 1 case of device migration were identified through 2 years, all in the control group.Device disassembly was noted in one activl patient and two controls.Heterotopic ossification interfering with range of motion was identified in 1.6% and 1.1% of patients treated with activl and control, respectively.The most commonly reported device-related serious adverse events (aes) were lumbar/leg pain and implant subsidence.Implant expulsion occurred in 0.9% of patients in the control group.The percentage of patients undergoing surgical reintervention at the index level was comparable between groups through 2 years.The reasons for reintervention were ongoing pain, device malposition, and lumbar spinal stenosis (activl group).This report is for an unknown pro-disc l polyethylene inlay and surgical reintervention due to device malposition.This is report 5 of 9 for (b)(4).

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5976857
• MDR Text Key: 55610710
• Report Number: 2530088-2016-10263
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• 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?: No
• Date Manufacturer Received: 08/29/2016
• 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