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

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/19/2015

Event Type  Injury  

Manufacturer Narrative

A total of 7 patients (3 females and 4 males) with an age ranging from 4 to 11 years were treated with magnetically controlled growing rods (mcgr).Exact date of event is unknown, january 19, 2015 is the date the literature article was published.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.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: giacomini, s., et al.(2015), magnetically controlled growing rod in early onset scoliosis, scoliosis vol.10(1), page 075 (italy) doi:10.1186/1748-7161-10-s1-o75.The aim of this study is to retrospectively review our patients treated with mcgr focusing on complications.A total of 7 patients (3 females and 4 males) with an age ranging from 4 to 11 years were treated with magnetically controlled growing rods (mcgr).In one case, an unknown synthes vertical expandable prosthetic titanium rib (veptr) was first implanted before using mcgr.In all cases, a dual growing rod was implanted, using as distal anchors pedicle screws, as proximal anchor hooks.The minimum follow-up was 6 months.The following complications were reported as follows: a revision was performed in 1 patient due to proximal hooks mobilization.This is for an unknown synthes vertical 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8732017
• MDR Text Key: 149122529
• Report Number: 8030965-2019-65701
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/31/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/25/2019
• 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