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 Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synfix cage/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: a.Anand et al.(2017) a novel approach to the thoracolumbar spine to s1 using visceral rotation to perform multilevel anterior lumbar interbody fusion (alif) for sagittal balance correction.The spine journal.Volume 17, pages s3-s22 ((b)(6)).The purpose of this prospective cohort study is to describe a novel truly anterior approach to the spine from t12 to s1 involving visceral rotation, preserving the diaphragm and avoiding entry into the chest cavity.The study also reports the approach-related complications and radiological outcomes of t12 to s1 anterior lumbar interbody fusion (alif)s performed.A total of 13 patients (4 males and 9 females with a mean age of 63 years) having multilevel alif using an unknown synthes synfix cages as part of a 2-stage complex spinal reconstruction for adult deformity from t12 to s1 were included for the study.Data was collected for operative time, blood loss, technical challenges, perioperative complications and need for secondary procedures.Mean follow-up was at 16 months (range 6-36 months).Complications were reported as follows; 1 case of patient death after the second stage from a pulmonary embolism was reported.2 cases of vascular injuries were reported.Both repaired uneventfully.2 cases of ileus were reported.An increase in lumbar lordosis from 5.80 (range 630-450) pre-operatively to 490 (range 340-640) post-operatively was reported.This report is for an unknown synthes synfix cage.This report is 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7882632
• MDR Text Key: 120520162
• Report Number: 8030965-2018-56398
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• 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: 08/27/2018
• 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