MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,SPINAL

Catalog Number UNK - PLATE

Device Problems Bent (1059); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Dysphagia/ Odynophagia (1815); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: for pseudoarthrosis, adjacent level degeneration.For screw displacement.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: song, k.-j., johnson, j.S., choi, b.-r., wang, j.C., lee, k.-b., anterior fusion alone compared with combined anterior and posterior fusion for treatment of degenerative cervical kyphosis (2010).Journal of bone joint surgery, volume 92-b, no.11, pp.1548-1552.(b)(4).The study was performed to evaluate the efficacy of anterior fusion alone compared with combined anterior and posterior fusion for the treatment of degenerative cervical kyphosis.The study was conducted between (b)(6) 2001 and (b)(6) 2007 and included a total of 30 patients (15 males; 15 females).Complications reported included the following: pseudarthrosis, revision surgery, hardware-related complications, dysphagia, infection, cage subsidence, adjacent level degeneration, and pain.This is report 1 of 2 for (b)(4).This is related to pseudarthrosis, revision surgery, dysphagia, hardware-related complications, infection, adjacent level degeneration, and pain.This report is for unknown cervical spine locking plates (cslp).

• Type of Device: APPLIANCE,FIXATION,SPINAL
• 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: 5403988
• MDR Text Key: 37306465
• Report Number: 2520274-2016-10638
• Device Sequence Number: 1
• Product Code: KWQ
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATE
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• 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