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

Device Problems Break (1069); Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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: kunkel, p., mladenov, k.And stücker, r.(2011), correction of congenital lumbar kyphosis associated with gibbus deformity with vertical expandable prosthetic titanium ribs (veptr): first results, european spine journal, vol.20, page 1994 (germany).The aim of this study is to evaluate the effectiveness of the application of veptr implants in the treatment of congenital lumbar kyphosis associated with gibbus deformity.A total of 6 patients with a mean age of 6.6 years (range 4.8-9.5 years) were included in the study.Surgery was performed by implantation of bilateral vertical expandable titanium ribs (veptr) clamped between the third and fourth rib and the posterior iliac crest.The mean follow-up period was 25.2 months (range 13-61 months).The following complications were reported as follows: 1 patient had a deep wound infection, which required a veptr-implant to be temporarily removed.In 25% of all planed lengthening procedure, implant revision had to be complemented, which includes undersized implants.In 25% of all planed lengthening procedures, implant revisions had to be complemented, which includes migrated and broken implants.This report is for an unknown synthes veptr.This is report 2 of 2 for complaint (b)(4).It captures reported event of migrated and broken implants which needs revision.

• 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: 8843814
• MDR Text Key: 152750430
• Report Number: 8030965-2019-66674
• 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: 07/04/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/30/2019
• 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