MAUDE Adverse Event Report: SYNTHES USA; PLATE, FIXATION, BONE

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Failure of Implant (1924); Pneumonia (2011); Respiratory Distress (2045); Septic Shock (2068); Paraplegia (2448); No Code Available (3191); Multiple Organ Failure (3261)

Event Date 02/25/2009

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.This report is for an unknown locking plate system.(other number) udi: unknown part number, udi is unavailable.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.(b)(4).Report was initially submitted on 10/31/2017 but the fda site was down.Advised by fda on 11/02/2017 to resubmit medwatch.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 journal article: flierl, m et al (2009) fatal outcome after insufficient spine fixation for pyogenic thoracic spondylodiscitis: an imperative for 360 degree fusion of the infected spine.Patient safety in surgery, vol.3, no.4, pp: 1-5.The present case study presents the catastrophic example of a (b)(6) year old female patient with inadequate initial fixation for thoracic spondylodiscitis, with a fatal outcome two weeks after revision surgery with 360 degree thoracic spine fusion.She presented to emergency department with severe thoracic back pain and progressive spastic paraparesis of her lower extremities.Spinal stabilization from t6 through t9 was performed by vertebral body replacement using an expandable titanium cage (synthes synex cage), autologous bone graft, and an anterolateral locking plate system (synthes).She healed in 2 weeks with decreased back pain, well healed surgical wounds without any signs of residual infection.Six months after the procedure, she presented again to the emergency department, secondary to a repeat fall, with clinical signs of acute paraplegia of the lower extremities.Emergent radiographic evaluation by conventional films and ct scan revealed a failure of fixation of the anterior thoracic spine, with a cranial pull-out of the cage and locking plate in the coronal plane, and kyphotic malunion in the sagittal plane.The constructs were fully removed and replaced with competitors devices.She developed bacteremia, meningitis, sepsis and eventually a septic shock.Blood cultures were positive for (b)(6), and the patient developed a p.Aeruginosa pneumonia, leading to acute respiratory distress syndrome.A spinal tap further revealed positive cerebrospinal fluid (csf) cultures for e.Coli, implying a gram-negative bacterial meningitis.Ultimately, the patient developed a secondary abdominal compartment syndrome which led to impaired ventilatory capacity and the requirement for an emergent decompressive laparotomy.Within two weeks of spinal revision surgery, the patient succumbed to these postoperative complications, as a consequence of refractory septic shock with multiple organ failure.This report is for an unknown locking plate system.This is report 2 of 2 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6998743
• MDR Text Key: 90942687
• Report Number: 2520274-2017-12565
• Device Sequence Number: 1
• Product Code: HRS
• 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: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• 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?: No
• Date Manufacturer Received: 10/04/2017
• 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
• Patient Age: 59 YR