MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synfix lr peek cage/unknown lot.Part and lot numbers are unknown; udi number is unknown.It is not known if device was explanted complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

This report is being filed after the subsequent review of the following literature article phan.K., davies.S., rao.P.J., mobbs.R.J.(2017).Worker¿s compensation status and outcomes following anterior lumbar interbody fusion: prospective observational study.World neurosurgery, 103, p.680-685.Australia.The purpose of the article is to identify whether worker¿s compensation (wc) status affects the clinical outcome and rates of complication following anterior lumbar-interbody fusion (alif) surgery.The study included 114 patients who underwent alif surgery between the years of 2012 through 2014.The patients were categorized into two groups, the first group were those with wc (24 patients), and the second group were those without wc (90 patients).Each of the patients were diagnosed with either degenerative disk disease without radiculopathy, degenerative disk disease with radiculopathy, or spondylolisthesis prior to their procedure.Each patient¿s body mass index (bmi) was captured prior to their procedure according to the world health organization as follows: class i (bmi <18.5, underweight), class ii (bmi 18.5-24.9, normal weight), class iii (bmi 25-29.9, overweight), and class iv (bmi 30-34.9, obese).All patients underwent alif surgery by a primary spine surgery with a vascular ¿access¿ surgeon and were implanted with a synfix-lr peek internal cage device (depuy synthes,(b)(4)) with 4 diverging intrinsic screws and an anterior locking plate, without anterior tension band plating or posterior instrumentation.The sizing of the implant varied across patients in accordance with the disk height of neighboring healthy lumbar disks, ranging from 12 to 19mm height with either an 8 or 12 degree lordotic angle to ensure sufficient distraction.Preoperative and postoperative scans were taken to capture in changes in the groups before and after the procedure.Analysis of intraoperative and postoperative variables identified no significant difference between the two groups.However, there were some notable findings discovered in both groups.There were several complications discovered in the non-wc group and 3 in the wc group.In the non-wc group, there were 3 wound infections, 2 postoperative ileus, 2 postoperative hematoma, 1 pneumonia, 1 wound dehiscence, 1 death, 4 pseudoarthrosis and 10 subsidence.In the wc group, there were 1 deep venous thrombosis, 1 pseudoarthrosis and 2 subsidence.A copy of the literature article is being submitted with this medwatch.This is report 2 of 3 for (b)(4).This report is for an unknown synfix-lr peek internal cage device with patient outcome: 2 postoperative ileus, 3 wound infections, 1 wound dehiscence, 4 pseudoarthrosis.

Manufacturer Narrative

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.(b)(4).

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7146708
• MDR Text Key: 95791316
• Report Number: 8030965-2017-50973
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• 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: 12/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention