MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

80 patients with adolescent idiopathic scoliosis, age 12-25 years, treated by posterior instrumented fusion were included in the study.The average age was 16 years and consisted of 72.5 percent females.This report is for an unknown synthes universal spine system (uss) construct/unknown lot.Part and lot number 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.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 abstract: duit r et al (2014).Quality in motion - a critical assessment of surgical treatment of adolescent idiopathic scoliosis.Nederlands tijdschrift voor orthopaedie.Volume 21.Number 2.(the netherlands).The goal of this study was to perform ¿check¿ with the aim of improving treatments as part of the ¿plan-do-check-act¿ concept (pdca cycle).In 2011, 80 patients with adolescent idiopathic scoliosis, age 12-25 years, treated by posterior instrumented fusion were included in the study.The average age was 16 years and consisted of 72.5 percent females.Hybrid instrumentation (expedium/favored angle screws (depuy spine), and unknown synthes universal spine system (uss) was used in all patients to create segmental fixation predominantly with pedicle screws and a limited number of hooks at the top end of the construction.Local bone graft was used, mixed with a 10 cc of an unknown synthes chronos beta-tricalcium phosphate granules.Patients had spinal cord monitoring using motor evoked potentials (tcmep).During the outpatient clinic visit, 3 months after discharge, both pain score and occurrence of complications were collected.Complications were reported as follows: 11 patients had greater than 2000 ml of blood loss intraoperatively.3 patients received donor transfusion after autologous transfusion.1 patient had an intraoperative dural lesion.The patient was treated with tissuecol, bed rest for 24 hours and prolonged antibiotics for 72 hours.3 patients had persistent pain (vas 2-3).2 of these patients were treated with oral pain medication while 1 was treated with an intercostal block.2 patients had persistent sagittal dysbalance.Patients underwent physiotherapy.This report is for an unknown synthes universal spine system (uss) construct.This is report 1 of 5 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.These dates were inadvertantly reported as 2/8/2019 in the initial report.The correct date is 2/21/2019.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.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8370403
• MDR Text Key: 137173898
• Report Number: 8030965-2019-61433
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention