MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, RIB REPLACEMENT

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number, the device history records review could not be completed as no product was received.The investigation summary: could not be completed; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: o¿brien a., et al (2015), management of thoracic insufficiency syndrome in patients with jeune syndrome using the 70mm radius vertical expandable prosthetic titanium rib, journal of pediatric orthopaedics, december 2015, volume 35 number 8 pages 783¿797 (usa).This retrospective study aims to radiographically and clinically assess efficacy and safety of a cohort of patients with jeune syndrome (js) treated with the veptr with relatively long follow-up and to describe the procedure in detail for the first time.Since 1991, a total of 24 patients (14 male and 10 female) were treated with staged bilateral dynamic posterior-lateral expansion thoracoplasty stabilized by a 70 mm radius unknown synthes veptr.Of these patients, 17 patients with a mean age 23 months (range, 7-62 months) were reviewed for clinical course.Patients were followed-up for a mean of 8.4 years (range, 2.3-15.6 years).The following complications were reported as follows: lumbar lordosis slightly increased, but not significantly 10 patients without scoliosis all developed scoliosis an average of 5 months (0 to 34 mo) after initial implant with an average of 29 degrees (12 to 45 degrees) at final follow-up.2 of the patients who had scoliosis before implant improved to < degrees, while 1 improved from 16-12 degrees, but 4 progressed.2 patients had worsening avr scores who were both avr+0 at preimplant.3 patients had superficial infection typically treated with just antibiotics.2 patients had superficial infection and had local debridement.1 patient had superficial infection which required hospital admission.4 patients had deep infections that required wound required wound debridement, sometimes device removal, and staged reimplantation.2 patients had wound dehiscence resolved without additional surgery.6 patients had wound dehiscence that required a single surgery, typically rotational skin flaps and/or debridement.10 cases of wound dehiscence that required multiple surgeries, either multiple debridement procedures or device removal with later reimplantation.1 case of wound dehiscence involved device removal with no further treatment in the program.3 patients had inadequate tissue coverage all requiring the placement and subsequent removal of tissue expanders.4 patients had pneumonia treated with antibiotics.22 patients had pneumonia requiring hospitalization.4 cases of pneumothorax required treatment with a chest tube.1 case of pneumothorax was treated with intubation without chest tube.2 cases of large pleural effusion were managed with extended intubation.4 cases of pleural effusion which required insertions of chest tube/pleural catheter for drainage (sv2) because the effusion was contributing to respiratory distress by compressing the lung.11 cases of other respiratory distress treated with hospital admission.3 patients had sepsis that required hospital admission and a course of antibiotics.8 patients subsequently required the additional implant of a 220mm radius hybrid veptr device to correct scoliosis.4 patients developed neck pain 3.5 years after thoracoplasty with c1-c2 instability and increased cervical stenosis noted and was treated with c1 decompression/occipital to c2 allograft fusion fracture (3 events in 1 patient).1 patient had breakage of the rib carriage rods (early veptr prototype) that occurred 3 times.2 case where the cradles were reseated during the routine scheduled implant exchange or expansion procedures by reseating the rib cradle on the reformed rib or replacing titanium slings on the ribs.12 patients had migration of the rib cradle/titanium slings.4 patients died during the treatment course with<2 years of follow-up.A case of a (b)(6) year old child had deep vein thrombosis at the right iliac and femoral vein postoperatively after device replacement and expansion, and requiring reintubation and heparin.This impacted product captures the following complications breakage of the rib carriage rods.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 2 of 3 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8791643
• MDR Text Key: 151111749
• Report Number: 2939274-2019-59191
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 06/19/2019
• 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