MAUDE Adverse Event Report: SYNTHES (USA); ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Pain (1994); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Patient weight was not provided by reporter.Additional device product codes are mni, mnh, kwp and kwq.This report is for two unknown titanium rods.Part and lot numbers were not provided by the reporter.Other¿udi# is unavailable.Date of initial implantation was reported as an unknown date in (b)(6) 2010.The subject device(s) are not expected to be returned to the synthes manufacturer for evaluation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 underwent revision surgery on (b)(6) 2016 due to pain, adjacent level disc disease and stenosis.Initially, the patient underwent a l4-s1 posterior lumbar fusion using synthes pangea instrumentation including six pangea screws, six pangea locking caps, and two unknown titanium rods on an unknown date in (b)(6) 2010.The patient developed pain on an unknown date in (b)(6) 2015.Examination revealed the patient had developed adjacent level disc disease and stenosis at the l3-l4 level above the l4-s1 fusion.During the (b)(6) 2016 revision surgery, all of the synthes pangea hardware from the 2010 surgery was removed.The screws at levels l4-s1 were replaced, and new synthes universal spine system screws were placed at l3 and the ilium.Decompression was performed at l3-l4.New rods were cut and contoured, and placed in position.The surgery was successfully completed.There were no issues or allegation of complaint reported in association with the pangea hardware from 2010; the patient had a solid fusion at the l4-s1 levels.This report is for two unknown titanium rods.This report is 5 of 5 for (b)(4).

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 5413593
• MDR Text Key: 37569550
• Report Number: 2520274-2016-10858
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• 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: 01/20/2016
• 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