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

Device Problem No Apparent Adverse Event (3189)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: pe´rez marti´n-buitrago m., et al (2014), effect of non-fusion techniques on vertebral rotation and the rib cage in early-onset scoliosis, eur spine journal, volume 23, pages 248¿288 (spain).This retrospective study aims to evaluate whether non-fusion techniques avert progression of vertebral rotation and the rib deformity.A total of 18 patients with an initial mean age of 6 +7 years, treated by non-fusion techniques were included in the study.Treatment was done using growing rods or veptr.Follow-up of 4 years was done.The following complications were reported as follows: analysis of the results confirmed a maintained improvement in cobb angle, but not in the vertebral rotation values and their effect on the ribs.The rib hump improved significantly following surgery (p\0.05), but relapsed to preoperative values during follow-up (p\0.05).There was a significant increase in rvad (metha) (p\0.05)between the postoperative and follow-up.This report is for an unknown synthes vertical expandable prosthetic titanium ribs (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: 8883398
• MDR Text Key: 153969201
• Report Number: 8030965-2019-67105
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/16/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• 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