MAUDE Adverse Event Report: SYNTHES USA; IMPLANT, FIXATION DEVICE, SPINAL

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Spinal Column Injury (2081); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown spinal device(s).(b)(4).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, sekhon, l.H.S.(2005).Posterior cervical lateral mass screw fixation analysis of 1026 consecutive screws in 143 patients.J spinal disorder tech(2005).Australia.This study evaluates the results and complications of 1026 consecutive lateral mass screws inserted in 143 patients by a single surgeon.Over a 50-month period, a total of 1026 lateral mass screws were placed in 143 patients ages 12¿96 years (56 females and 87 males), with these records retrospectively reviewed.A variety of different implants were used including synthes' and competitors' devices.There is no correlation between reported complications and synthes/competitor's devices.This report is for the following complications: dural tears(3), deep infection, c5 root injury(1), adjacent segment requiring surgery(1), hematoma requiring evacuation(1).This is report #2 of 3 for (b)(4).This report is for a variety of different implants including synthes' and competitors' devices.

• Type of Device: IMPLANT, FIXATION DEVICE, 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: 5191440
• MDR Text Key: 29975377
• Report Number: 2520274-2015-16933
• Device Sequence Number: 1
• Product Code: JDN
• 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: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• 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?: No
• Date Manufacturer Received: 10/14/2015
• 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