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

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Pneumonia (2011); Pneumothorax (2012); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

Event Description

Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: el-hawary, r.Et al (2020), veptr treatment of early onset scoliosis in children without rib abnormalities: long-term results of a prospective, multicenter study, journal of pediatric orthopedics, vol.40 (6), pages e406¿e412 (canada).The aim of this multicenter, observational, prospective study is to hypothesize that long-term (ie, 5 y) veptr treatment of eos without rib abnormalities similarly prevents scoliosis progression and allows spinal growth.Between january 2007 to january 2015, a total of 59 patients (33 male and 26 female) with a mean age of 6.1±2.4 years were included in the study.Surgery was performed using a vertical expandable prosthetic titanium rib (veptr); depuy synthes spine, raynham, ma.The mean follow-up was 6.9±1.4 years.The following complications were reported as follows: 2 patients died.11 patients had converted to other growth-friendly devices.3 patients had veptr explanted.Although secondary scoliosis curve improved immediately after veptr implantation (39±20 to 33±20 degrees), recurrence was observed to a comparable magnitude as preoperatively (42±19 degrees).In 18% of patients, the major curve was deteriorated at the last overall follow-up.In 51% of patients, the minor curve was deteriorated at the last overall follow-up.In 50% of patients, the maximum kyphosis was deteriorated at the last overall follow-up.In 4% of patients, the t1-t12 height was deteriorated at the last overall follow-up.In 12% of patients, the t1-t12 sagittal length was deteriorated at the last overall follow-up.In 12% of patients, the t1-s1 sagittal length was deteriorated at the last overall follow-up.In 21% of patients, the composite success (major curve, t1-t12, and t1-s1 heights) was deteriorated at the last overall follow-up.42 patients (71%) experienced at least 1 complication, with 105 total complications observed (table 6).Among these, 68 were device-related and 32 were disease related (table 7).16 patients had spine infection.9 patients had wound dehiscence.8 patients had implant failure.8 patients had pain.7 patients had pneumonia.6 patients had other wound complication.5 patients had other medical illness.5 patients had other respiratory illness.4 patients had prominent implant.3 patients had other fracture.2 patients had abdominal injury.2 patients had neurological injury.2 patients had rib fracture.1 patient had cardiac arrest.1 patient had pneumothorax 24 patients had device migration.This report is for an unknown synthes veptr constructs.This report is for (1) unk - constructs: veptr.This is report 1 of 2 (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, 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.

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11340823
• MDR Text Key: 241128628
• Report Number: 2939274-2021-00923
• 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: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

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
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 01/27/2021; 04/22/2021
• Supplement Dates FDA Received: 04/20/2021; 04/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention