MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.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 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: ventura, n., batlle, a.E.And vilalta, i.(2011), complications of veptr instrumentation for progressive spine deformities in young children without rib fusions, european spine journal, vol.20 (supplement 4), page s544 (spain).The aim of this retrospective study is to evaluate the clinical and radiographic result of 29 patients treated with veptr for correction of early onset scoliosis without rib fusions and to describe the complications.A total of 29 patients with a mean age of 6.7 years were included in the study.Surgery was performed using vertical expandable prosthetic titanium rib (veptr).The follow-up period was a minimum of 2 years to maximum of 6.8 years.The following complications were reported as follows: 1 patient died 6 months after surgery due to cardio-respiratory arrest.Postoperative curve degree between 37° and 79° (55°).Postoperative kyphosis was 31° ¿73° (42°).Postoperative space available for the lung between 0 and 63% (22%).4 patients developed skin sloughs and all of them required implant removal (two of these cases were treated with growing rods 6 months later).1 patient had acute infection at the distal anchorage that required debridement and intravenous antibiotics.1 patient had distal junctional kyphosis that required distal pedicle screws.1 patient had 2 rod breakages that required revision surgery.1 patient had 1 distal hook dislodgement that required revision surgery.1 patient had iliac hook pelvic migration without clinical translation.This report is for an unknown synthes veptr construct.This is report 1 of 4 for complaint (b)(4).It captures the adverse events of surgical intervention, medical device removal, kyphosis, infection and wound healing delayed (skin sloughs that required device removal).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8841882
• MDR Text Key: 152679183
• Report Number: 8030965-2019-66656
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/30/2019
• 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