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

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 05/18/2005

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; may 18, 2005 is the date the literature article was published.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: hell, a., campbell, r.M., and hefti, f.(2005), new treatment concept for children with thoracic insufficiency syndrome due to congenital spine deformity, vol.217(5), pages 268-273 (germany).The purpose of this study is to gradually expand and support the spinal column over the thorax to allow growth of the same, the thorax and the lungs.Since may 2002, a total of 15 patients (7 female and 8 male) with an average age at surgery of 6 years (11 months to 12 years) were included in this study.Most children suffered from unilaterally unsegmented bars with fused ribs (n = 4), neuromuscular scoliosis (n = 6) and bilateral fused ribs (n = 2).Other patients also showed a combination of hemivertebra formation (n = 3), chondrodysplasia epiphysaria punctata (n = 1), pronounced sprengel's deformity (n = 1), and missing ribs (n = 2), which led to paradoxical breathing.All children suffered from a constricted hemithorax with thoracic insufficiency syndrome.In children with neuromuscular diseases this was caused by severe thoracolumbar scoliosis.The following complications were reported as follows: a (b)(6) years of age had rib fracture with hook tear out.This report is for an unknown veptr construct.This is report 2 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8885029
• MDR Text Key: 154537432
• Report Number: 8030965-2019-67132
• 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: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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
• Date Manufacturer Received: 07/17/2019
• 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