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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 05/13/2006

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown screw, uss construct/unknown quantity/unknown lot.Additional product codes: mni, mnh, kwp and kwq.(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.Report was initially submitted on oct 1, 2015, but the fda site was down.Advised by fda on oct 9, 2015 to resubmit medwatch.Report was initially submitted on oct 1, 2015, but the fda site was down.Advised by fda on nov12, 2015 to resubmit medwatch.Report was initially submitted on oct 1, 2015, but the fda site was down.Advised by fda on nov17, 2015 to resubmit medwatch.Report was initially submitted on oct 1, 2015, but the fda site was down.Advised by fda on dec 9, 2015 to resubmit medwatch.Report was initially submitted on oct 1, 2015, but the fda site was down.Advised by fda on dec 16, 2015 to resubmit medwatch.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; lange et al.(2007) anterior vertebral body replacement with a titanium implant of adjustable height: a prospective clinical study.Eur spine j 16: 161-172.This study was a prospective investigation of the 50 patients who received stabilisations of the thoracic and lumbar spine carried out with the synex titanium vertebral body replacement between feb 10th, 1999 and may 3rd, 2000.The patient group consisted of 21 women and 29 men with an average age of 43.1 (20-77) years at the time of the operation.Out of 50 patients 47 patients were given a combined operation receiving a dorsal internal fixator (uss) with at least one additional cross-link.In remaining 3/50 patients operated upon exclusively from the anterior side, bisegmental instrumentation was performed using one or two non-synthes plate fixators.In 30/50 patients the synex was employed bisegmentally, while in 20/50 anterior spinal fusion was carried out monosegmentally.Complications reported: (n=1) failure of the lower pedicle screws.Following bony integration the internal fixator was removed and the patient became almost free of symptoms.This is report 3 of 5 for (b)(4).This report is for an unknown screw, uss construct.

• 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: 5301585
• MDR Text Key: 33591669
• Report Number: 2520274-2015-16350
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• 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