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 Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown vertical expandable prosthetic titanium rib (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: gantner as.Et al (2018), spinal deformity changes in children with long-term vertical expandable prosthetic titanium rib treatment, the spine journal, volume 18, pages 567-574, (germany).This retrospective study aimed to evaluate spinal deformity in scoliotic children and to investigate the correction potential of vertical expandable prosthetic titanium rib (veptr) implants at several time points of treatment, particularly after long-term follow-up.32 children with spinal deformity who underwent implantation of unknown synthes vertical expandable prosthetic titanium rib (veptr) implants between ribs and pelvis (bilateral) or ribs and lumbar spine (unilateral) with repetitive expansion surgeries approximately every 6 months were included in the study.In 18 children, the veptr devices were placed unilaterally whereas 12 children received bilateral veptr treatment.There were 24 females and 8 males with a mean age at implantation were 7.8 years (range 0.8¿13.9 years).The follow-up period was 5.5 years on average (range 2.6¿11.8 years) complications were reported as follows: unknown patients have deteriorated thoracic curve with an average of 55 degrees at the 5.5-year follow-up from an average of 45 degrees immediately after surgery.On unknown patients, the longer follow-up of 5.5 years has induced worsening of the lumbar curve at with no significant change to the preoperative value of the lumbar cobb angle.Unknown patients have kyphosis correction that could not be maintained during follow-up or restored by any subsequent lengthening procedure.Kyphosis tended to intensify by time above the initial value (25.5 degrees at 5.5 years follow-up).This report is for one (1) device- 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8755419
• MDR Text Key: 149921514
• Report Number: 8030965-2019-65965
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• 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: 06/05/2019
• 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