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 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: garcia, p.Et al (2018), comparison of short-term complications in patients with early onset scoliosis between vertical expandable prosthetic titanium rib and magnetic growing rods, european spine journal, vol.27, page 2683 (canada).The objective of this study is to compare the complication rates observed throughout the first post-operative year in patients with eos treated with veptr or mgr.A total of 35 patients were included in this study.20 patients were treated with veptr and 15 patients with mgr.Demographic data, complications and reintervention throughout the first year after the surgery were retrospectively collected.The following complications were reported as follows: postsurgical complication rate at one year was significantly higher in veptr (75% vs 6.7%).Reintervention rate at one year was significantly greater in veptr (50% vs 6.7%).Regarding the secondary endpoint, correction of the cobb angle (p.001) and avt (p.002) were significantly higher in mgr.This report is for a vertical expandable prosthetic titanium rib (veptr).This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.This complaint has been determined to be a duplicate of (b)(4).For this reason, this complaint (b)(4) will be voided.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.

Event Description

Update: this complaint has been determined to be a duplicate of (b)(4).For this reason, this complaint will be voided.

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8879375
• MDR Text Key: 153844996
• Report Number: 8030965-2019-67066
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

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
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention