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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for an unknown syn-mesh cage / unknown quantity / unknown lot.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 subsequent review after the subsequent review of the following literature article: beril g (2008) surgical treatment of cervical spondylotic myelopathy with anterior compression: a review of 67 cases.J neurosurg spine 9:152-157.Usa.Cases were reviewed involving patients with cervical spondylotic myelopathy treated via an anterior approach, paying special attention to neurological outcome, fusion rates, and complications.Retrospectively, 67 cases involving patients with cervical spondylotic myelopathy requiring an anterior decompression were reviewed: 46 patients, 21 men and 25 women, ranging in age from 31 to 79 years of age, wo underwent anterior surgery only (1- to 3-level anterior cervical discectomy and fusion [acdf] or 1-level corpectomy), and 21 patients, 12 men and 9 women, ranging in age from 36 to 67 years, who required 3-level acdf or 2-level corpectomy underwent anterior surgery supplemented by a posterior instrumented fusion procedure.For corpectomy procedures, reconstruction and arthrodesis was performed using titanium cages (synmesh, synthes or competitor product) filled with local autograft, allograft, and bone putty.Anterior plating (cslp small stature and variable angle, synthes) was used in all discectomy and corpectomy cases.Variable angle screws were used with all anterior plates.Complications: one patient underwent reoperation for an epidural hematoma.One patient experienced postoperative unilateral deltoid weakness that resolved within 10 weeks of operation.Three patient experienced adjacent-segment disease.One patient developed infection that was successfully treated with a single debridement procedure.One patient one patient required re-exploration for repair of cerebrospinal fluid fistula and pseudomeningocele after anterior surgery.One patient who underwent a single level acdf, underwent posterior decompression and instrumentation for adjacent level stenosis 4 years later and has remained in stable condition for 2 months since.One patient who underwent 2 level acdf developed adjacent -segment disease 2 years later and underwent single level adjacent segment acdf and remained in stable condition for 1 month at follow up.One patient who underwent single level acdf was found to have kyphotic deformity at the adjacent level 3 years postoperatively and underwent posterior fusion and has remained in stable for condition for 2 months postoperatively.One patient who underwent 2- level corpectomy and posterior fusion developed progressive neck pain 5 months postoperatively.Imaging studies revealed failure of the plate with maintained position of the cage.Since the cage was in a good position, the patient underwent removal of the plate, additional arthrodesis, and subsequent fusion, and his neck pain resolved.This is report is 2 of 6 for (b)(6).This report is for an unknown synmesh cage and refers to the following complication: one patient experienced hardware removal, pullout of the lower part of the plate and screws and settling of the cage into the c6 vertebral body) occurred in a patient who underwent a c-5 corpectomy.A c-6 corpectomy and reconstruction with an expandable cage and plate was performed with supplemental posterior instrumentation.

• 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: 5218697
• MDR Text Key: 30969841
• Report Number: 2520274-2015-17023
• 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
• Type of Report: Initial
• Report Date: 10/12/2015

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: 10/12/2015
• Initial Date FDA Received: 11/11/2015
• 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