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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Paresis (1998); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article; (october 2012) ¿stand-alone anchored spacer versus anterior plate for multilevel anterior cervical diskectomy and fusion.¿ yang; orthopedics healio.Com/orthopedics; october 2012|volume 35 - november 10.This article reports on a study total of 51 consecutive patients with cervical spondylotic myelopathy that compared surgical parameters, clinical and radiological outcomes, and complications in patients who underwent three or four level anterior cervical discectomy and fusion with stand along anchored implants that were divided into 2 groups.(zero p implant) group a or with an anterior plate system (syncage)group b.Technique related complications reported on implant group b (syncage) are: one case of cerebrospinal fluid leakage occurred due to a dual tear intro operatively due to tight adhesion.Patient recovered after three to five days of local pressure.Also reported were hoarseness, epidural hematoma, cage subsidence and c5 palsy.One patient on group b developed epidural hematoma recovered neurological function after emergency evacuations and pulse methylprednisolone therapy.No long term neurological deficit was observed.This report is for 2 of 2 implants for com-(b)(4).Unknown syncage implant, unknown quantity/unknown part number and unknown lot number.(group b) a copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Stand-alone anchored spacer versus anterior plate for multilevel anterior cervical diskectomy and fusion.Orthopedics (b)(6); october 2012|volume 35 - november 10.This report is for unknown syncage implant, unknown quantity, unknown item number, (b)(4) the investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot and 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.

• 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: 4584211
• MDR Text Key: 21242705
• Report Number: 2520274-2015-11548
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• 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: 02/16/2015
• 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