MAUDE Adverse Event Report: SYNTHES USA; ROD

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Nflex is not currently available for the us market; however, it is available in the ous market.The nflex stabilization system is intended for use with pedicle screw fixation in skeletally mature patients to provide controlled dynamic stabilization of the lumbosacral spine.Similar stabilization systems are available in the us market thus this complaint is being reported.This report is being filed after the subsequent review of the following journal article by jeffrey d.Coe, md et al: nflex dynamic stabilization system: two-year clinical outcomes of multi-center study published in the journal of korean neurosurgical society 51: 343-349, 2012.This was a retrospective study of 72 consecutive patients, from 5 sites, who underwent nflex stabilization, between september 2006 and july 2007, at one level with or without rigid fusion at a continuous level.Of these 72 patients, 65 were available for 2-year follow-up.Study group: 65 patients (men = 26, women = 39); mean age of 54.5 years ranging from 19-86; mean follow-up was 25.6 months, ranging 23-24 months.Inclusion criteria: patients were included based on the presence of degenerative disc disease (n = 29), degenerative spondylolisthesis (n = 16), lumbar stenosis (n = 9), adjacent segment degeneration (n = 6), and degenerative lumbar scoliosis (n = 5).Preoperative imaging studies: x-rays and in most cases, computed tomography and magnetic resonance imaging (mri).Follow-up evaluations: 3 and 6 weeks (one center assessed patients at 4 weeks), 3 months, 6 months, 12 and 24 months; some were conducted through.In some cases, follow-up evaluations were conducted through phone interviews.Radiographic assessments included evidence of instrumentation failure or screw loosening.Implant details: single dynamic level (non-fusion) (n = all); two single-level dynamic constructs at non-contiguous levels (l3-l4 and l5-s1 (n = 2); instrumented rigid fusion performed at contiguous levels (so called ¿hybrid fusion¿) (n = 40); non-fusion dynamic stabilization without fusion segments (n = 25); two-level rigid fusion combined with one level dynamic stabilization and (n = 8)3-level rigid fusion plus one level dynamic stabilization.(n = 4).Dynamic stabilization was used at the contiguous superior level in patients (n = 33) receiving the ¿hybrid¿ fusion, and was placed at the inferior end of the fused segment(s) in 7 (18%) of patients receiving the hybrid fusion.The most common pathology was for ddd at 1 or 2 levels.This is report 5 of 9 for (b)(4) for nflex system for the following complications: one patient with re-operation due to advanced osteoporosis and cage migration (1) at a non-dynamic (fusion) level.And another patient had re-operation for a loose locking cap on a pedicle screw with screw loosening.This patient had a dynamic level l1-l2 but no screws could be placed in l2.Therefore, the dynamic segment spanned l1-l3 which likely created an usually long lever arm causing the screw to loosen.No identifiable details provided.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report is for an unknown quantity of a nflex rod with an unknown part and lot number.Nflex is not currently available for the us market; however, it is available in the ous market.The nflex stabilization system is intended for use with pedicle screw fixation in skeletally mature patients to provide controlled dynamic stabilization of the lumbosacral spine.Similar stabilization systems are available in the us market thus this complaint is being reported.(b)(6).Without a lot number the device history records review could not be completed.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.(b)(4).

Manufacturer Narrative

Originally reported: and another patient had re-operation for a loose locking cap on a pedicle screw with screw loosening.Revised: the patient had re-operation due to a loose locking cap, and did not have screw loosening.Screw loosening occurred with a different patient and will be processed separately.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient had re-operation due to a loose locking cap, and did not have screw loosening.Screw loosening occurred with a different patient and will be processed separately.

• Type of Device: ROD
• 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: 3971887
• MDR Text Key: 4750057
• Report Number: 2520274-2014-12944
• Device Sequence Number: 1
• Product Code: NQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2014
• 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