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 Bone Fracture(s) (1870); No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown expandable prosthetic titanium rib (veptr) construct/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: lorenz, h.Et al (2017), magnetically controlled devices parallel to the spine in children with spinal muscular atrophy, jbjs open access: december 28, 2017 volume 2(4) pages e0036 (germany) doi: 10.2106/jbjs.Oa.17.00036.This study aims to assess the level of control of spinal deformity in a homogeneous group of patients with spinal muscular atrophy(sma) who were managed with magnetically controlled implants for 2 years.Between 2011 and 2015, a total of 21 non-ambulatory children (11 male 10 female) with type-ii sma who underwent surgical implantation of the magnetically controlled device and had subsequent lengthening procedures were included in the study.Four(4)of the 21 patients had previously undergone bilateral implantation of a expandable prosthetic titanium rib (veptr) device with rib-to-pelvis fixation at a mean of 2.5 years prior to the implantation of the magnetically controlled device.During conversion surgery, the initial fixation anchors were retained in all 4 patients.All 21 patients were managed with bilateral insertion of the magnetically controlled device(magec [magnetic expansion control]; ellipse technologies) with use of veptr rib-to-pelvis fixation.The mean duration of follow-up was 2 years.The following complications were reported as follows: 1 patient had a superficial infection that was treated with intravenous antibiotics without implant exchange.Cobb angle had initially decreased from 55 to 16 (p = 0.017) after the implantation of the previous veptr device but had worsened to 31 after a mean duration of follow-up of 2.5 years.1 patient experienced rib fracture.2 patients had 6 lengthening failure procedure.1 obese patient experienced 4 lengthening failure procedure leading to a surgical revision.1 patient had implant dislocation because of a difference in implant diameters and underwent surgical correction with the use of a connector.1 patient experienced rib fracture and required surgical revision of the rib cradle.This report captures the following complication: cobb angle worsened to 31 after a mean duration of follow-up, rib fracture, lenghtening procedure, revision.This report is for an unknown synthes expandable prosthetic titanium rib (veptr) construct.This is report 1 of 3 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: 8732786
• MDR Text Key: 149135958
• Report Number: 8030965-2019-65723
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• 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: 05/29/2019
• 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