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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: veptr ii/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: lorenz, h.M.Et al (2019), surgical "no-touch" distraction technique to correct pediatric scoliosis, operative orthopädie und traumatologie, vol.31 (xx), pages 321¿334 (germany).The aim of this study is to present this distraction technique to correct pediatric scoliosis.Between november 2011 to september 2018, a total of 45 patients (21 male and 24 female) with an average age of 7.2 ±2.1 years underwent 495 percutaneous expansions.Surgery was performed using veptr®-i or veptr®-ii system (depuy synthes, johnson & johnson medical gmbh, german division in umkirch) in combination with a competitor device.The follow-up period was 3.5 ±2.1 years.The following complications were reported as follows: 9 patients were converted from a classic veptr system to a magec system after an average of 2.8 years.A total of 19 implant-associated complications (mainly dislocations) required surgical revision in 13 patients (3.7%) and 16 complications (mainly inability to extend the implants percutaneously) required conservative treatment in 8 patients (3.1%).This report is for an unknown synthes veptr ii constructs.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR II
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11385740
• MDR Text Key: 241048865
• Report Number: 8030965-2021-01401
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 02/04/2021
• 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