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 Paralysis (1997); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between 1996 and 2015.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.(b)(4).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

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: mikhaylovskiy, m.Et al (2016), progressive scoliosis and syringomyelia - questions of surgical approach, folia medica, vol.60 no.2, pages 261-269 (russia).The purpose of this retrospective analysis study is to evaluate the outcome of surgical correction of the scoliotic deformity in syringomyelia patients.Between 1996 and 2015, a total of 33 patients required surgical correction of the syringomyelia-associated scoliosis.Of these patients 4 patients with a mean age of 5.8 years (range, 2.5-8.5 years) were treated with unknown synthes veptr.Follow-ups were unknown.The following complications were reported: 2 patients required neurosurgical treatment.In both cases, the spinal deformity continued to progress after neurosurgical treatment.This report is for an unknown synthes veptr construct.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: 8759857
• MDR Text Key: 149999823
• Report Number: 8030965-2019-65999
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/03/2019
• 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