MAUDE Adverse Event Report: SYNTHES USA; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

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

Patient Problems Pain (1994); Sedation (2368)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a revision of l4-l5 arthroplasty to anterior lumbar inter-body fusion (alif) was performed on (b)(6) 2015.Primary surgery was on (b)(6) 2012.Primary surgery was an l4-l5 arthroplasty and l5-s1 fusion.Prodisc l used for arthroplasty and synfix was fusion.Per the surgeon and scans provided on (b)(6) 2015 the pro disc l prosthesis had fish-mouthed while looking at an ap view (opened up on the left side, and closed down on the right.) osteophytes growing around the left side of the implant.Patient was complaining of pain and insisted that the device be taken out.Vascular surgeon was available to help with access to the disc, but found it impossible to safely mobilize the blood vessels.There was a lot of tissue scarring and veins were stuck down.Six (6) hours into access, there was visibility of the prodisc l prosthesis, however it was impossible to safely remove and revise to alif.Surgeon decided to drill out the osteophyitc bone grown around the device.Surgeon then proceeded to drill out two thirds of the polyethelene inlay leaving the metal endplates intact.Surgeon's plan is to come back another week and perform a posterior lateral fusion.(b)(4).

Manufacturer Narrative

This report is for an unknown synfix implant/unknown lot.It is unknown if the synfix implant was explanted during the revision procedure on (b)(6) 2015.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chseter PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4950105
• MDR Text Key: 19357467
• Report Number: 2520274-2015-15057
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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: 07/15/2015
• 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