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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following literature article vitale, m., & et al.(2008).Health-related quality of life in children with thoracic insufficiency syndrome.Journal of pediatr orthop (28) 239-243.A study was conducted to compare the quality of life (qol) of children with thoracic insufficiency syndrome (tis) and the impact on their parents before implantation of the veptr and to those same parameters after the implantation.The study also compared the qol of children with tis and the parental impact before implantation of the veptr with previously published qol of healthy children.As part of the original multicenter evaluation of the veptr, a child health questionnaire (chq) was collected preoperatively on 45 patients who were subsequently treated with expansion thoracoplasty using the veptr.Postoperative data within 6 months of initial implantation or any veptr-related surgical procedures were excluded from the analyses.There were only 37 postoperative chq-pf50 data in the analyses.There were 21 boys (56.8%) and 16 girls (43.2%) in the postoperative data.The average age was 8.2 t 2.6 years, and the parent form of the chq was filled out by the primary caretaker.Patients were divided into 3 diagnostic categories: rib fusion (n = 15), hypoplastic thorax syndromes (n = 17), and progressive spinal deformity (n = 13).The chq-pf50 was designed to assess the functional status and psychosocial well-being of children 5 years and older and relative burden of care on parents.The chq-pf50 includes 15 domains and 50 items.The domains were global health, physical functioning, role/social limitations-emotional/behavioral, role/social limitations-physical, bodily pain/discomfort, behavior, mental health, self-esteem, general health perceptions, parent impact-emotion, parent impact-time, family activities, family cohesion, physical summary, and psychosocial summary.The preoperative assessment was conducted at 47.1 ± 76.0 days on average (range, 0-276 days) before the surgery.The postoperative chq-pf50 data were collected at 32.6 ± 16.9 months on average from the initial surgery (range, 9-91 months).Approximately 30% of patients experienced veptr-related complications.Five patients (13.5%) experienced infections, 3 patients (8.1%) had device migration, 2 patients (5.4%) had both infection and device migration, and 1 patient (2.7%) had dermatologic complication.Most patients (70.3%) did not experience any complications related to veptr surgeries.There were significant differences between the study patients and healthy children in physical domains.Compared with parents of healthy children, parents of children with tis experienced more limitations on their time and emotional lives due to their children¿s health problems.There were no significant differences in chq before and after the surgery except for a significant decrease in the self-esteem among a subgroup of patients with hypoplastic thorax syndromes.There were no significant differences in postoperative qol between patients who had veptr-related complications and patients who did not have the complications.This report is against 1 veptr regarding a device migration.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Vitale, m., & et al.(2008).Health-related quality of life in children with thoracic insufficiency syndrome.Journal of pediatr orthop (28) 239-243.This report is for unknown veptr and unknown lot number.(b)(6).Dermatological complication.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot or part numbers were 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: 4602715
• MDR Text Key: 17295368
• Report Number: 2520274-2015-11730
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/15/2015
• Initial Date FDA Received: 03/16/2015
• 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