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 Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr construct/unknown lot.Part and lot number 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.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.(b)(4).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: marques, c.Et al (2019), surgical treatment of scoliosis developed after extended chest wall resection due to askin tumor during childhood , spine deformity, volume 7(1),january 2019, pages 180-185 (spain).This retrospective study aims to analyze a short series of pediatric cases with scoliosis, developed after extended surgical chest wall resections of askin tumors, describing their management and midterm results.A total of four cases (1 male 3 female) with an average age of 8.7 -2.2 years the day that the chest wall surgery was performed and who developed scoliosis needing surgical correction were included in this study.Vertically expandable prosthetic titanium rib (veptr) devices and traditional growing rods were used to treat the deformity.In the first two cases, a veptr device was used, whereas traditional growing rods (tgrs) were used in the last two cases.The average final follow-up was 6.9 - 3.6 years.The following complications were reported: a case of a 7.(b)(6) year-old girl was initially treated with a bilateral veptr device graduated with a final reconstructive spinal posterior instrumented fusion.A case of a 6.(b)(6) year-old boy initially treated with a bilateral veptr device.During lengthenings, a proximal junctional kyphosis occurred, and he was converted to traditional growing rods.No changes were observed regarding preoperative kyphosis.This report is for an unknown synthes vertically expandable prosthetic titanium rib (veptr).This is report 1 of 1 for (b)(4).

• 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: 8745376
• MDR Text Key: 149547054
• Report Number: 8030965-2019-65870
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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
• Date Manufacturer Received: 06/04/2019
• 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
• Patient Age: 6 YR