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

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

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 for an unknown s-hook and includes the following events: it is unknown which of the following events involved surgical intervention with an unplanned surgery, a revision or were treated at the next planned surgery: 13 of the 18 sliding s-hook complications were after the initial procedure and were treated by replacing of the s-hook correctly on the iliac crest - s-hook sliding out of iliac crest (laterally, n=11, radiograph images provided of lateral sliding of hook out of iliac crest), (medially, n=7, radiograph images provided of medial sliding of hook out of iliac crest); 3 patients had a change in construct due to distal migration more than 2cm (radiograph image provided); and one had a change in construct due to a hook fracture.This is 2 of 2 reports for (b)(4).A copy of the literature article is being submitted with this medwatch.This report is for an unknown veptr s-hook.

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 s-hook for an unknown quantity/unknown lot.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; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4180017
• MDR Text Key: 5154676
• Report Number: 2520274-2014-14162
• 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?: Yes
• 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