MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Wound Dehiscence (1154); Pneumonia (2011); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown vertical expandable prosthetic titanium rib.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown vertical expandable prosthetic titanium rib.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: wimmer c, wallnoefer p, pfandlsteiner t (2010), operative treatment of scolioses with the ¿vertical expandable prosthetic titanium rib¿ (veptr) instrumentation , operative orthopaedics and traumatology, volume 22, pages 123-136, (germany).The goal of surgery is to lengthen and expand the constricted concave hemithorax to the height of the convex sides to increase thoracic volume, to obtain thoracic symmetry, to improve thoracic function, to maintain these improvements during growth of the child, and to avoid growth inhibition procedures, if possible.From 2005 to 2009, 39 patients who were diagnosed with scoliosis and treated with an unknown synthes vertical expandable prosthetic titanium rib (veptr) were included in the study.There were 24 females and 15 males with a mean age of 7.5 years (range, 3 to 13 years).A total of 39 primary implantations, 126 lengthening procedures and 24 implant replacements were performed.The latter were necessary because a curvature in the other direction had occurred, or because the patient had grown to such an extent that the implants were too small.In follow-up surgeries at intervals of 4¿6 months, the devices are expanded through a limited incision at their base to maintain correction with growth.The children underwent surgery between 1 and 9 times.The veptr implant was removed and replaced with a pedicle screw system.In the first weeks, the children are immobilised with an orthesis if they are in pain, and their mobility is restricted.The follow-up examinations were performed every 3 months.The mean follow-up was 34 months (2¿60 months).Complications were reported as follows: 7 cases had detached hook after lengthening.3 patients developed pseudobursa.1 patient had impaired wound healing.1 patient had pneumonia.1 patient had wound dehiscence.1 patient had to have the implant partially removed.A total of 7 revisions were required resulting in repeat placement of the hook, partial removal of the implant or extension down to the lumber spine.This report is for unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 2 for (b)(4).

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8659277
• MDR Text Key: 146681937
• Report Number: 8030965-2019-64751
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/02/2019

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: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• 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