MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Irritation (1941); Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: m loibl, et al.(2005).Spinal fracture reduction with a minimal-invasive transpedicular schanz screw system: clinical and radiological 1 year follow up.Injury, int.J.Care injured , 46s4, pp.S75-s82.This report is for unknown (device name)/unknown quantity/unknown lot.Unknown part number, udi is unavailable.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article: m loibl, et al.(2005).Spinal fracture reduction with a minimal-invasive transpedicular schanz screw system: clinical and radiological 1 year follow up.Injury, int.J.Care injured , 46s4, pp.S75-s82.Authors: switzerland.The aim of this prospective non-randomized cohort study was to generate first results reflecting the clinical and radiological outcome of patients treated with percutaneous dorsal instrumentation for fractures of the thoracic and lumbar spine with the use of a transpedicular new schanz screw system (universal spine system fracture.Depuy synthes).26 patients total with fractures of the thoracic and lumbar spine operatively treated with bi-segmental dorsal instrumentation between january and december 2012.22 patients completed clinical follow-up.21 patients completed radiological follow up.Study cohort comprised of 12 women and 14 men.Mean age: 47.4 +/- 4.1 years.Bmi mean: 22.9 +/- 0.7.Fractures were found in various parts of spine: the thoracic, thoraco-lumbar spine, and lumbar.Radiological data acquisition performed: pre- and postoperatively, after 6 weeks, 3, 6 and 12 months.The radiological parameter: cobb angle.Clinical outcome parameter: chronic disability index, oswestry disability index, and spine tango core outcome measurement index.Authors did not define rating scale therefore, the results will not be included.Complications: dissatisfied patients with result of surgery: 2, very dissatisfied patients with result of surgery: 1 1 year after the surgery, back pain kept 5 patients from going to work between 1-7 days during the past 4 weeks, and 2 patients were not able to work at all.The ability to perform sports activities at the time of follow-up compared to the ability before the accident was rated as ¿worse¿ by 9 patients and as ¿impossible¿ by 3 patients.At 1 year follow-up, the patients reported pain with intensity of 2.7 +/- 0.5 (range 0-6).Painkillers for the reason of back pain were used ¿more than once a day¿ by 3 patients and ¿occasionally¿ by 3 patients.Physical therapy was still performed by 9 patients.2 patients applied a home rehabilitation program.At the 1 year assessment, 1 patient showed a remaining irritation of the lateral femoral cutaneous nerve after removal of the iliac crest bone graft.Extent of loss of reduction after 6 weeks- 4.6 +/- 1.4 degree.Loss of reduction for dorsal treatment - 5.8 degree.Loss of reduction for dorso-ventral treatment- 2.8 degree.Loss of reduction after first 6 weeks- 8.7 degree; at 1 year follow-up- 4.9 degree.Loss of reduction after 1 year in comparison to postop state- 6.9 +/- 1.3 degree among all patients.Loss of correction 12 months postop on average with dorsal treatment- 8.7 degree.Loss of correction 12 months postop on average with additional ventral support ¿ 4.9 degree.2 revision surgeries performed due to a postoperative hematoma without infection.This is report 1 of 2 for (b)(4).This report is for an unknown universal spine system.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5401194
• MDR Text Key: 37186814
• Report Number: 2520274-2016-10569
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• 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