MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2014

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown synthes synapse polyaxial screw-rod implants, unknown item number/unknown quantity/unknown lot.Additional product codes- nkg.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 complaint has been initiated after review of the following article: park, jun hee; kim, sang hyun; cho, ki hong.(2014) "clinical outcomes of posterior c2-c3 fixation for unstable hangman's fracture compared with posterior c1-c3 fusion." korean j spine.2014 jun;11(2):33-8.Doi: 10.14245/kjs.2014.11.2.33.Epub 2014 jun 30.The purpose of this study was to determine the clinical outcomes of posterior c2-c3 fixation for unstable hangman's fracture compared with posterior c1-c3 fixation.In this study twenty four patients for unstable hangman's fracture were enrolled between july 2007 and june 2010 in this study.Thirteen patients underwent posterior c2-c3 fusion and 11 patients underwent posterior c1-c3 fusion using synapse polyaxial screw-rod synthes.Clinical outcomes were evaluated using neck disability index (ndi) scores and visual analogue scale (vas) scores during preoperative and postoperative follow up period.Plain radiographs were obtained on postoperative 1 day, 1 week, and then at 1, 2, 6, and 12 months.Ct was done at postoperative 12 months in all patients for evaluation of bone fusion.The mean period of clinical follow-up was 15 months.The results showed that the mean ages were 43.3 years in c2-c3 group and 50.0 years in c1-c3 group.Mean follow-up period was 17.2 months in c2-c3 group and 16.3 months in c1-c3 group.Vas scores and ndi scores in c2-c3 group were much less than those in c1-c3 group at each follow-up period.The differences of vas score and ndi scores between c2-c3 and c1-c3 groups at each follow-up period were statistically significant (p<0.001) by paired t-test.Solid bone fusion was confirmed in all cases at the final follow-up.In conclusion c2-c3 group showed better clinical and biomechanical results than c1-c3 group in terms of axial pain and disability of neck.Complications included: it was reported that one patient with screw loosening in the c2-c3 group using the synthes synapse polyaxial screw-rod implants.Revision surgery was performed for screw repositioning.(rm-si) this report is for 2 of 2 items for (b)(4).This report is for an unknown synthes synapse polyaxial screw-rod implants, unknown part number and lot number.

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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: 5192453
• MDR Text Key: 29995605
• Report Number: 2520274-2015-16727
• Device Sequence Number: 1
• Product Code: KWP
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 10/30/2015
• 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