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

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

Patient Problem Neck Pain (2433)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article chang, h., baek, d., & byung, w.(2014).The relationship between increased intervertebral disc height and development of postoperative axial neck pain after anterior cervical fusion.J korean neurosurg soc 55 (6): 343-347.The purpose of this study was to evaluate the relationship between postoperative increase in intervertebral disc space height (ivh) and posterior axial neck pain during the postoperative and follow-up periods in cases of degenerative cervical disease treated with anterior cervical discectomy and fusion (acdf).The study population consisted of a total of 155 patients who underwent acdf between january 2011 and march 2012 with more than 1 year follow up.A total of 107 patients were men and 48 were women, with a mean age of 55.1 years (range, 32¿78 years).Of the patients, 128 had cervical radiculopathy and 27 had cervical myelopathy.A total of 113 patients had a single-level fusion, whereas 42 had 2-level fusion.The fusion level of surgery was c3-4, c4-5, c5-6, c6-7, and c7-t1 in 13, 31, 95, 55, and 3 cases, respectively.All the patients implanted a stand-alone cage (zero-p).The implant was packed with local bone tissue obtained from the surgical site and dbx demineralized bone matrix be¬fore insertion.After surgery, the patients each wore a philadelphia brace for 2 weeks.Radiologically, ivh and interfacet distance (ifd) of the operated segment were measured preoperatively and postoperatively.Neck and arm pains were clinically evaluated according to visual analogue scale (vas) scores and assessed neck disability index (ndi) scores preoperatively, postoperatively, at 3 months, 6 months, and 1 year postoperatively.The relationship between radiological parameters, and clinical scores were analyzed using a regression analysis.Fifty-five patients (35.4%) showed sustained neck pain during the follow-up period.Thirty patients complained of neck pain at postoperative 3 months; 27, at postoperative 6 months; and 21, until postoperative 1 year.The correlation analysis between preoperative neck vas scores and neck vas scores during follow up period showed a significant relationship.Regarding treatment of postoperative neck pain, 25 patients used medication, 12 patients used physical therapy, and 2 patients used a medial branch block procedure.There was no significant difference in clinical outcomes according to the treatment method.The overall results showed a mean increase in ivh was 2.62 mm, and the mean increase in ifd was 0.67 mm.The vas scores for neck pain preoperatively, postoperatively, and at 3 months, 6 months, 1 year postoperatively were 4.46, 2.11, 2.07, 1.95, and 1.29; those for arm pain were 5.89, 3.24, 3.20, 3.03, and 2.18.The ndi scores were improved from 18.52 to 7.47.No significant relationship was observed between the radiological evaluation results regarding the increase in intervertebral height or interfacet distance and clinical changes in vas or ndi scores.In conclusion, the increase in intervertebral space or interfacet distance by the insertion of a large graft material while performing acdf for the treatment of degenerative cervical disease was not related with the change in vas scores for neck and arm pains and ndi scores postoperatively and during the follow-up period.This is report is for an unknown number of zero-p implants.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Chang, h., baek, d., & byung, w.(2014).The relationship between increased intervertebral disc height and development of postoperative axial neck pain after anterior cervical fusion.J korean neurosurg soc 55 (6): 343-347.This report is for unknown zero-p/unknown quantity/unknown lot.(b)(6).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.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• 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: 4592063
• MDR Text Key: 5470414
• Report Number: 2520274-2015-11575
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/11/2015
• 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