MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS, INTERVERTEBRAL DISC

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

Patient Problems Laceration(s) (1946); Arthralgia (2355); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article: zigler, j (2004).Lumbar spine arthroplasty using the prodisc ii.The spine journal 4, 260s ¿ 267s.Usa.This article represents data on the first 78 patients involved in an investigation device exemption study in the united states, prospectively comparing implantation of a prodisc with a 360-degree fusion, with both single- and double-level study arms.The 78 patients involved in this study all had at least a 6-month follow up and 54 of the patients had a 1-year follow up.These patients were enrolled in a prospective randomized fda study evaluating the safety and efficacy of prodisc ii versus control, a 360-degree lumbar spinal fusion.The data from this study was collected from the texas back institute.Of the 78 patients involved in the study, 55 patients received the artificial disc replacement and 23 patients received a circumferential spine fusion.Ten patients underwent single-level disc replacement before the two-level arm of the study began.Data was collected preoperatively, perioperatively, and at intervals of 6 weeks, 3 months, 6 months, and 1 year postoperatively.Outcome data collected included the visual analog scale (vas) assessing pain, the oswestry low back pain disability questionnaire, and patient satisfaction rates.There were no intraoperative complications in the fusion group.In the disc replacement group, one patient required reintervention on the first postoperative day because of dislodgement of the polyethylene spacer, which had been improperly inserted.It was replaced without further complications.One patient had an iliac vein laceration that was repaired during the index procedure without consequence or need for transfusion.Postoperatively, one patient in the fusion group complained of bilateral leg pain, which was treated with neurontin and had resolved by the 3-month follow-up.One deep wound infection requiring operative irrigation and debridement occurred posteriorly in a fusion patient.In the disc replacement group, one patient presented with a superficial wound infection, which resolved after a course of oral antibiotics, one patient had sacroiliac joint pain (managed with steroid injections and chiropractic management with partial relief), and two patients developed right left pain, managed with neurontin and epidural injections.At the 6-month follow-up, both patients with leg pain had some residual pain controlled with oral medication, and the patient with sacroiliac joint pain was involved in a car accident, which reactivated the symptoms.All patients with leg symptoms had surgery at the l5-s1 disc space, but no other associated factor was found.One prodisc patient was successfully treated medically for pelvic deep venous thrombosis.This report is for the following event: the one patient that had an iliac vein laceration that was repaired during the index procedure without consequence or need for transfusion; postoperatively, the one patient in the disc replacement group presented with a superficial wound infection, which resolved after a course of oral antibiotics; postoperatively, the one patient that had sacroiliac joint pain that was managed with steroid injections and chiropractic management with partial relief (at the 6-month follow up, the patient with sacroiliac joint pain was involved in a car accident, which reactivated the symptoms); and postoperatively, the two patients who developed right leg pain, managed with neurontin and epidural injections (at the 6 month follow up, both patients with leg pain had some residual pain controlled with oral medication).This is report 5 of 6 for (b)(4).This report is for an unknown prodisc-l, inferior endplate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Zigler, j (2004).Lumbar spine arthroplasty using the prodisc ii.The spine journal 4, 260s ¿ 267s.This report is for an unknown prodisc-l inferior endplate/unknown quantity/unknown lot.Udi: unknown part number, udi is unavailable.(b)(6).(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.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: 4770995
• MDR Text Key: 16182133
• Report Number: 2530088-2015-10168
• 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: 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: 05/14/2015
• 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