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 Pain (1994); Loss of Range of Motion (2032); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: kim, y.Et al (2011), nonfusion method in thoracolumbar and lumbar spinal fractures, spine, vol.36 (no.2), pages 170-176 (south korea).The aim of this retrospective study is to evaluate the results of posterior stabilization of thoracolumbar fracture using nonfusion method followed by the removal of metal implants within an appropriate period.Changes in the sagittal alignment and the restoration of segmental motion were also investigated.Between january 2002 to may 2006, a total of 23 patients (11 men and 12 women) with a mean age of 28 years, underwent a posterior fixation using a pedicle screw system: screw and the rod ¿ universal spine system (uss), but without fusion.Ambulation was started within 2 days after surgery and a thoracolumbosacral orthosis brace was applied for 6 to 8 weeks after surgery.Patients were observed in an outpatient department, and implants were removed at 9.75 months on an average (range: 6¿17 months).After removal, follow-up periods ranged from 18 to 73 months (mean, 22.75 months).The following complications were reported as follows: before the implant removal, the mean sagittal angle was 1.7 kyphosis (range: 16 kyphosis-15 lordosis), thus loss of reduction before removal was 4.5.A (b)(6) lady with a flexion-distraction injury at l2 showed 26.7 kyphotic segmental angulation between l1 and l3 (a), which became 18.3 lordotic after posterior fixation (figure 1).1 patient with 35° kyphosis by gross inspection showed severe kyphotic deformity during final follow-up.2 patients had a minor deformity, but the deformities were not noticed by the patients.All patients had a foreign body sensation.Out of these, 17 patients had a stiff back.Both disappeared after the implant removal.5 patients reported that bending the back was not as easy as it was before injury.2 patients complained of intermittent lower back pain, but it did not affect daily activity.This report captures reported event of kyphosis, pain, loss of anatomical alignment after fracture reduction, joint range of motion decreased (uneasy bending of the back), surgical intervention, medical device removal and medical device site reaction (foreign body sensation).This report is for an unknown synthes universal spine system (uss).This is report 1 of 2 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: 8570204
• MDR Text Key: 143807832
• Report Number: 8030965-2019-63345
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 04/03/2019
• 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