MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Muscular Rigidity (1968); Neuropathy (1983); Pain (1994); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: ramirez, norman et al.Use of the s-hook for pelvic fixation in rib based treatment of early onset scoliosis: a multicenter study.Spine publish ahead of print, doi: 10.1097/brs.0000000000000443.The purpose of this study was to evaluate how several pre-operative variables affect the outcome using the rib to pelvis s-hook constructs of a rib based distractions implant, veptr, in 7 institutions, members of the chest wall deformity study group.Surgeries were performed between august 2003 and august 2008.All veptr requiring distal iliac fixation contributed by each center were consecutive and included in the study.The study population included: 65 patients (38 male, 27 female); mean age at initial procedure was 71 months, ranging 1 year and 7 months to 9 years and 6 months; mean follow up was 46 months, ranging 2 years and 7 months to 5 years and 9 months.No patients were lost to follow-up.Forty of the patients had a healthy bmi, 15 were underweight and 10 were overweight at the initial surgery.Thirty nine patients had a neuromuscular spine deformity and 26 had a congenital deformity.Thirty three were non-ambulatory and 32 were ambulatory.Inclusion criteria: evidence of progressive early onset, treated with a rib based growing distraction system using s-hook rib to pelvis construct, with a minimum of 2 years follow-up after the initial procedure.Radiological variables were evaluated based on the preoperative, immediate and last postoperative radiographs.The s-hook position in relation to the iliac crest was evaluated and the hook positions were ranked into 3 categories: top of the dome, medial to the top, and lateral to the top.Surgery details included the positioning of the construct were: left side s-hooks positioned over ilium (n=46), medial side (n=11), and lateral side (n=5); right side s-hook positioning: over top (n=47), medial side (n=8), and lateral aspect (n=4); average initial implantation time: 3 hours and 6 minutes, ranging 1 hour and 18 minutes to 7 hours and 40 minutes; proximal anchor placement at: t3/t4 level (n=35), t2/t3 level (n=19), t4/5 (n=6), t5/6 (n=4), and t9/10 (n=1); one proximal incision (n=59); domino connector used (n=52 cases); double rod construct used (n=56); and the s-hook prong was positioned posterior to the iliac crest (n=39) and positioned ventral to iliac crest (n=26).This complaint is for an unknown veptr construct, including an unknown s-hook, unknown connector, and an unknown rod.This report is for an unknown veptr system for the following events: there were 4 patients with neuropathic pain treated successfully with gabapectin.Five patients had infections and 2 of them had their implants removed.The authors identified the surgical time in all infected cases was over 3 hours, with staphylococcus aureus as the most common organism.The infected patients were treated with incision and drainage followed by antibiotics.Among the ambulatory patients, 13 developed crouched gait after the procedure.The authors noted that situation may be secondary to the distraction over the iliac crest that retroverts the pelvis and results in knee flexion and ankle dorsiflexion.In addition, the authors noted that those patients that developed post-operative crouched gait had a high association with the complications.This is report 1 of 2 for (b)(4).This report is for an unknown veptr.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ramirez, norman et al.Use of the s-hook for pelvic fixation in rib based treatment of early onset scoliosis: a multicenter study.Spine publish ahead of print, doi: 10.1097/brs.0000000000000443.This report is for unknown veptr with unknown quantity/unknown lot.(b)(4) implant removal and crouched gait.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: PROSTHESIS, RIB REPLACEMENT
• 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: 4180003
• MDR Text Key: 5162544
• Report Number: 2520274-2014-14156
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• 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
• Date Manufacturer Received: 09/19/2014
• 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