MAUDE Adverse Event Report: SYNTHES USA; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight is not available for reporting.This report is for one (1) unknown synfix evolution spacer.Part#, lot# and udi # is not available.Device product code xxx used for code ovd.Device is not explanted.Still in patient.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown synfix evolution spacer.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent an l3-4, l5-s1 anterior lumbar interbody fusion (alif) on (b)(6) 2016 with a synfix evolution implanted at both levels.There was no posterior instrumentation on the initial procedure.On an unknown date, the patient fell on her deck at home and the l3-4 synfix evolution migrated anteriorly.The device is still intact but now proud of the l3-4 disc space.The patient was brought back for a l3-4 posterior lateral fusion on (b)(6) 2016.Patient and surgery outcome were not reported.Concomitant devices reported: synfix evolution (quantity 1).This report is for one (1) unknown synfix evolution spacer.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

X-ray review results: the synfix plate does appear to be proud anteriorly at the l3/4 level form the x-ray images provided.Ap view also indicates the device at l3/4 is not truly mid-line.The use of these devices at two non-continuous levels are off label though.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reportedly there was three (3) hours surgical delay during surgery.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6234054
• MDR Text Key: 64213058
• Report Number: 2520274-2017-10095
• Device Sequence Number: 1
• Product Code: OVD
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• 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
• Treatment: ONE (1) UNKNOWN SYNFIX EVOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR