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

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

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

Event Date 02/19/2014

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes vertical expandable prosthetic titanium ribs (veptr)/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: thakar, c., rolton, d.And nnadi, c.(2014), the surgical treatment of complex early onset syndromal scoliosis using a remotely expandable device, european spine journal, vol.23 (no.1), pages s93-s139 (united kingdom).The aim of this study is to demonstrate potential applications of the magec system in complex syndromal scoliosis.A total of 3 patients (2 males and 1 female) were included in the study.Of the 3, only 1 patient was treated using vertical expandable prosthetic titanium ribs (veptr) but was removed and converted with a competitor device.The following complications were reported as follows: case 3: (b)(6) year-old boy with vacterl syndrome and in situ tracheostomy required multiple revisions complicated by infection.General anaesthesia was complicated by respiratory compromise.A competitor device inserted after removal of veptr.Distraction was performed at 6 months due to concerns about the proximal fixation.This report is for an unknown synthes vertical expandable prosthetic titanium ribs (veptr).This is report 1 of 1 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8719366
• MDR Text Key: 148760465
• Report Number: 8030965-2019-65537
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2019

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: 05/27/2019
• Initial Date FDA Received: 06/20/2019
• 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: 4 YR