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

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

Patient Problems Wound Dehiscence (1154); Muscle Weakness (1967); Nerve Damage (1979); Undesired Nerve Stimulation (1980); Impaired Healing (2378); No Code Available (3191)

Event Date 12/19/2011

Event Type  Injury  

Event Description

This is a retrospective review for the following literature article: hrabalek, l., adamus, m., wanek, t., machac, j., & tucek, p.(december 2012.).Surgical complications of the anterior approach to the l5/s1 intervertebral disc.Biomedical papers of the medical faculty of the university palacký, olomouc, 156(4), 354-358.Purpose: to report prospectively the incidence and specific types of perioperative complications that occur with minimally invasive anterior retroperitoneal spinal surgery performed at level of the l5/s1 intervertebral disc.All cases of anterior surgery at level l5/s1, treated from january 2001 to february 2011.Population: 175 patients (103 females, 72 males), average age 45 years (range 24¿76 years).Preoperative diagnoses: degenerative disc disease (n=87), failed back surgery syndrome (n=53) and spondylolisthesis (n=35) and failed conservative treatment for their low back pain and radiculopathy after a 6 month minimum.Complications that occurred directly related to the anterior spinal surgery were recorded.Complications related to implant healing were not included.Surgical details: syncage or synfix, peek visios, synthes or competitor implant used for anterior lumbar interbody fusion (alif), their iliac crest or vertebral body bones and chronos were impacted into spacer as well as anteriorly for fusion, and prodisc-l or competitor implants used for total disc replacement (tdr).Additionally, alif was performed (n=143), including 85 patients with a stand-alone fusion, 12 patients with concomitant anterior plating-oracle and 46 patients with additional posterior transpedicular fixation -uss, and arthroplasty (tdr) was done in 32 patients.Although synframe retractor blades were utilized to expose the anterior intervertebral circumference, synframe is not an implant and there were no complications involving its use.Despite preoperative planning, 19.4% of intraoperative pathological-anatomical anomalies were the cause of potential complications and led to more difficult surgeries in these cases.Postoperative care and follow-up:alif cases had mobility restrictions, tdr cases had no restrictions; follow up visits with the surgeon and radiographs occurred at 6 weeks, 6, 12 and 24 months.At follow-up:x-rays confirmed no hardware failures, patients were not worse after surgery, and 164 patients satisfied with surgery and reported improvement.This is for the following associated with this unknown device, uss: not improved (n=11) and had followup posterior transpedicular fixation at l5/s1 segment surgery to enhance enhancement stability; intraoperative:peritoneal opening without visceral injury (n= 9) and vascular injury of small veins (n=2); postoperative: wound incompetence (n=2), right abdominal wall weakness (n=5), right sided sympathetic dysfunction (n=2), and hypesthesia of right groin and thigh (n=1).This is report 7 of 7 for (b)(4).This report is for an unknown uss.

Manufacturer Narrative

Hrabalek, l., adamus, m., wanek, t., machac, j., & tucek, p.(december 2012.).Surgical complications of the anterior approach to the l5/s1 intervertebral disc.Biomedical papers of the medical faculty of the university palacký, olomouc, 156(4), 354-358.This report is for unknown uss for unknown quantity/unknown lot.(b)(6).(b)(4).Intraoperative:peritoneal opening without visceral injury (n= 9) and vascular injury of small veins (n=2).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.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.

• Type of Device: ORTHOSIS,PEDICLE 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: 4274580
• MDR Text Key: 5028938
• Report Number: 2520274-2014-14942
• Device Sequence Number: 1
• Product Code: MNI
• 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: 10/31/2014

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: 10/31/2014
• Initial Date FDA Received: 11/24/2014
• 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