MAUDE Adverse Event Report: SYNTHES USA; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Impaired Healing (2378); Reaction (2414); No Code Available (3191)

Event Date 01/14/2011

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for an unknown synex spinal system , unknown item number/unknown quantity/unknown lot.Kyphotic deformity.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; hofstetter c.P et al (2011) posterior approach for thoracolumbar corpectomies with expandable cage placement and circumferential arthrodesis: a multicenter case series of 67 patients.J neuro spine 14: 388-397.This article reports on a multicenter trial was to investigate the outcome and durability of a single-stage thoracolumbar corpectomy using expandable cages via a posterior approach.The authors conducted a retrospective chart review of 67 consecutive patients who underwent single-stage thoracolumbar corpectomies with circumferential reconstruction for pathological, traumatic, and osteomyelitic pathologies.Circumferential reconstruction was accomplished using expandable cages along with posterior instrumentation and fusion.Correction of the sagittal deformity, the american spinal injury association score, and complications were recorded.The results state that approximately one-half of the patients remained neurologically stable.Improvement in neurological function occurred in 23 patients , whereas 7 patients suffered from a decrease in lower-extremity motor function.The deterioration in neurological function was due to progression of metastatic disease in 5 patients.Five constructs failed-3 of which had been placed for traumatic fractures, 1 for a pathological fracture, and 1 for an osteomyelitic fracture.Other complications included epidural hematomas in three patients and pleural effusions in two.In conclusion single-stage posterior corpectomy and circumferential reconstruction were performed at multiple centers with a consistent outcome over a wide range of pathologies.Correction of the sagittal deformity was sustained, and the neurological outcome was good in the majority of patients; however, of acute traumatic fractures required revision of the construct.Complication for this report: patient 2 was a (b)(6) female at the time of the event.Patient suffered burst fracture mechanical failure of spine at level l1 with kyphotic deformity and retropulsion of bone fragments due to a high speed motor vehicle accident.Patient was instrumented at level t12-l2 for a single stage corpectomy with allograft and autograft.Postoperatively at 2 months, patient suffered from kyphosis complication and subsidence of cage at l2 interface.At 3 months after surgery patient was showing progression of subsidence and a high grade kyphotic deformity.Patient had revision surgery treatment.This report is 2 of 13 for complaint (b)(4).This report is for an unknown synex spine system implants for unknown part number, lot number.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 5058277
• MDR Text Key: 25099227
• Report Number: 2520274-2015-15637
• Device Sequence Number: 1
• Product Code: MQP
• 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: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• 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
• Patient Age: 16 YR