MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Bone Fracture(s) (1870); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown synthes universal spine system (uss)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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: briem d, rueger jm, linhart w (2003).Osseous integration of autogenous bone grafts following combined dorso-ventral instrumentation of unstable thoracolumbar spine fractures.Original unfallchirurg.Volume 106.Page 195-203.(germany).The goal of this prospective study was to evaluate the results of autogenous bone grafts using computed tomography and record the local complications at the removal location.Between 1999 and 2000, 30 patients with injury to the thoracolumbar junction were included in the study.There were 17 women and 13 men with an average age of 40.7 +/-2.51 years.Upon completion of the presurgical diagnostics, patients underwent posterior stabilization using an unknown synthes universal spine system.Subsequently, an anterior arthrodesis was performed by autogenous iliac bone grafting in combination with an osteosynthesis.In the first stage of the study, a conventional open procedure was used for stabilization in 14 patients using an unknown synthes ventrofix.Over the course of the study, a minimally invasive technique for anterior stabilization was used in 16 patients using a competitor¿s device.Postoperatively, follow up examinations were performed after 6 and 12 months.Prior to removal of the dorsal implant after 12 months (10-16 months) computed tomography is performed and the integration of the iliac crest graft is then evaluated using these images.The authors did not specify which 14 patients were implanted with the ventrofix system.Thus, complications will be reported as follows: (patient 1) a (b)(6) female patient had radiological indications of partial fusion with resorption zones adjacent to the graft.The patient did not have any signs of progressive correction loss in the form of a relevant kyphosis at the time of the ct imaging and later.(patient 5) a (b)(6) female patient had radiological indications of partial fusion with resorption zones adjacent to the graft.The patient did not have any signs of progressive correction loss in the form of a relevant kyphosis at the time of the ct imaging and later.(patient 13) a (b)(6) male patient had radiological indications of partial fusion with resorption zones adjacent to the graft.The patient did not have any signs of progressive correction loss in the form of a relevant kyphosis at the time of the ct imaging and later.(patient 25) a (b)(6) male patient had radiological indications of partial fusion with resorption zones adjacent to the graft.The patient did not have any signs of progressive correction loss in the form of a relevant kyphosis at the time of the ct imaging and later.(patient 27) a (b)(6) male patient had radiological indications of partial fusion with resorption zones adjacent to the graft.The patient did not have any signs of progressive correction loss in the form of a relevant kyphosis at the time of the ct imaging and later.(patient 19) a (b)(6) male patient had osteonecrosis in the transplant with as subsequent fracturing of the graft.(patient 26) a (b)(6) female patient had osteonecrosis in the transplant with as subsequent fracturing of the graft.An average correction loss of 4.244 +/- degrees for the entire patient collective (t=12 +/-2.4 months) regardless of the osseous fusion measured using the base-cover plate angle.This complaint involves a total of 12 impacted products.Due to limitation of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4).This report is for a (b)(6) male who had osteonecrosis in the transplant and subsequent graft fracture.This report is for an unknown synthes universal spine system (uss).This is report 9 of 10 for (b)(4).

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 8629140
• MDR Text Key: 145682607
• Report Number: 8030965-2019-64291
• Device Sequence Number: 1
• Product Code: MNH
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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: 04/23/2019
• 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
• Patient Age: 48 YR