MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SURGICAL MESH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

Event Date 12/01/2009

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown vertebral body replacement - expandable: synex/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: hartmann e., heintel t., morrison r., weckbach a., (2009), influence of platelet-rich plasma on the anterior fusion in spinal injuries: a qualitative and quantitative analysis using computer tomography, archives of orthopaedic and trauma surgery, july 2010, volume 130(7), pages 909¿914(germany) doi 10.1007/s00402-009-1015-5.This study aims to evaluate the effects of platelet-rich plasma (prp),which is known to play an important role in the new formation of bone following fractures or the implantation of bone grafts,in patients undergoing an anterior spinal fusion using cages.Between 2004 to 2006 a total of 17 patients who had sustained a traumatic fracture of the lower thoracic or lumbar spine and had undergone an anterior fusion using cages were included in the study.Two patients declined to take part in their scheduled follow-ups for personal reasons.Fifteen patients (10 male 5 female) were available for follow-up examinations.Twelve patients were initially stabilised using a rigid posterior fixation device.In a second step, the anterior destruction was bridged using a titanium implant.This was an expandable cage (synex® synthes inc., germany) in nine cases of bridging or a non-expandable device (synmesh®, synthes inc., germany) bridging one segment combined with an anterior plate system in the other six cases.In addition to this rigid fixation, a mixture of bone graft drawn out of the fractured vertebra and prp had been placed onto the left side of the cage using a thoracoscopically assisted technique.The ct scans were made 8.33 months (4¿15) postoperatively.Another group, a control group, made up of 20 patients (13 male 7 female) with a mean age of 39.8 years (range 18¿64), that had suffered an unstable spinal injury requiring anterior fusion and did not have prp injected additionally had a similar treatment, consisting of an initial rigid posterior fixation combined with an anterior reconstruction using a titanium cage.Seven patients also received an anterior plate system.The follow-ups took place 12.5 months (range 4¿30) postoperatively.The following complications were reported as follows: platelet-rich plasma (prp) group: 3 patients (20%) had no or minimal bony fusion.6 patients (40%) had incomplete ossification.Control group: 6 patients (30%) had no or minimal bony fusion.6 patients (30%) had incomplete ossification.This report is for an unknown synthes expandible cage.This is report 1 of 2 for (b)(4).

• Type of Device: SURGICAL MESH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8760059
• MDR Text Key: 150004786
• Report Number: 8030965-2019-66005
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• 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: 06/07/2019
• 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