MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Nerve Damage (1979); Pain (1994); Thrombosis (2100); Tissue Damage (2104); Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment not diagnosis lowey, g , kulkarni, s (2000).Posterior percutaneous spine instrumentation.Eur spine j 9 (suppl 1) :s126¿s130.This report is for an unknown uss connector, unknown quantity / unknown lot number.(b)(4) 2 patients underwent hardware removal due to prominent hardware, 5 patients underwent hardware revision for either screw replacement or mild discomfort of their hardware; 3 patients had obvious intradiscal nonunions, 1 patient had iliac vein injury , 8 patients experienced transitional syndrome above and below the fusion, 4% of patients had unsuccessful fusion.1 patient had screws removed due to transient foot drop, 2 patients had screws removed due to persistent foot drop.7 patients had malposition of screws and underwent revision.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot 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: lowey, g , kulkarni, s (2000).Posterior percutaneous spine instrumentation.Eur spine j 9 (suppl 1) :s126-s130.Eighty consecutive cases of suprafascial pedicle screw stabilization were reviewed.There were 39 men and 41 women studied with an average age of 45 years.The average follow up was 12 months.Posterior stabilization involved the application of titanium shanz screws into the pedicles and titanium uss rod and connectors are attached.A variety of materials were employed for the anterior composite conduit graft.During routine outpatient hardware removal, all intradiscal fusions were stressed via the shanz screws under fluoroscopy.Clinical and radiographic examinations were reviewed.This is report 3 of 3 for (b)(4).This report is for an unknown uss connector and refers to the following complications: 5 patients underwent hardware revision for either screw replacement or mild; discomfort of their hardware; 7 patients had malposition of screws and underwent revision; 2 patients underwent hardware removal due to painful and prominent hardware; 3 patients had obvious intradiscal nonunions; 3 patients had arterial thrombosis; 1 patient had iliac vein injury; 8 patients experienced transitional syndrome above and below the fusion; 2 patients had deep wound infections; 4% of patients had unsuccessful fusion; 5 patients had isolated radicular symptoms; 1 patient had screws removed due to transient foot drop; 2 patients had screws removed due to persistent foot drop.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 5113398
• MDR Text Key: 27176974
• Report Number: 2520274-2015-16272
• 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,litera
• Reporter Occupation: Pharmacist
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 09/11/2015
• 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