MAUDE Adverse Event Report: SYNTHES (USA); ORTHOSIS, SPINAL PEDICLE FIXATION

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Thrombosis (2100); Weakness (2145); Impaired Healing (2378)

Event Date 04/24/2014

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: turunen, v.Et al (2012) lumbar instrumented posterolateral fusion in spondylolistheic and failed back patients: a long-term follow-up study spanning 11-13 years.Eur spine j 21:21040-2148.The patients examined in this study underwent lumbar instrumented fusion operations between the years 1992-1997.The 106 patients (67 female; mean age at operation 50.6 years) were divided into four groups based on symptoms, clinical status findings, and appropriate finding in radiological examinations (native x-ray, myelography, ct, mri).The follow-up study was carried out during the years 2005-2008.In the first few operations, dick¿s fixation device (ao) was used.A few patients were treated with instrumentation of 2 other competitor manufacturers.Uss (steel) devices (synthes) were used starting in 1994.X-rays were taken in the outpatient clinic after 2 and 4 months and 1 and 2 years after the operation.Adverse events reported were as follows.One patient experienced deep thrombosis in legs, 8 patients were operated for adjacent segment disease, 3 patients required fusion and/or decompression of the adjacent segment , and 1 patient experienced postoperative hematoma.Two patients reported dissatisfaction with their results, 2 patients were revised due to non-unions, 1 patient required re-decompression of the fusion area, and 2 patients reported peroneal weakness.Deep infection was treated in 2 patients (1 with meningitis that required reoperation) and there was one infection that was related to the epidural stimulator that required reoperation to remove the stimulator.One patient had to undergo re-spondylodesis operation, adjacent segment fusion, and implant removal in another facility, one patient had an unplanned removal due to chronic pain with poor results, one patient suffered a nerve injury and urine retention that did not heal, 53 patients reported pain at follow-up, and there were 21 unplanned revisions for a total of 16 patients in the study.This report is 2 of 3 for (b)(4).The article does not distinguish which manufacturer was associated with the complications.This complaint is for an unknown quantity of uss steel and dick¿s fixation devices.A copy of the journal article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Turunen, v.Et al (2012) lumbar instrumented posterolateral fusion in spondylolisthetic and failed back patients: a long-term follow-up study spanning 11-13 years.Eur spine j 21:21040-2148.The article does not distinguish which manufacturer was associated with the complications.This report is for an unknown quantity of uss steel and dick¿s fixation devices.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
• 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: 4287998
• MDR Text Key: 5079460
• Report Number: 2520274-2014-14741
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• 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: 11/06/2014
• 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