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

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

Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown vertical expandable titanium prosthetic rib (veptr) constructs/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.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

This report is being filed after the review of the following journal article: helenius i.J.Et al (2019) results of growth-friendly management of early-onset scoliosis in children with and without skeletal dysplasias a matched comparison, bone joint and journal volume 101-b, pages 1563¿1569 (finland) doi:10.1302/0301-620x.101b12.Bjj-2019-0735.R1.This retrospective study aims to explore the outcomes, in terms of surgical correction and hrqol, following growth-friendly surgical management of eos, comparing children with skeletal dysplasia to a matched group of children with idiopathic eos.Between 1997 and 2016, a total of 568 children with a skeletal dysplasia who underwent growth-friendly spinal instrumentation were retrospective reviewed.33 children were eligible for inclusion.The mean age of patients at index surgery was 5.3 years (1.5 to 10.1) in the skeletal dysplasia group and 5.4 years (1.8 to 9.6) in the idiopathic group.In each group, the index surgery was carried out using growing rods in 20 patients (13 traditional and seven magnetically controlled dual growing rods) and veptr instrumentation in 13 patients.Mean duration of follow-up after index surgery was 5.6 years (1.5 to 13) in the skeletal dysplasia group and 7.1 years (2.1 to 16) in the control group.The following complications were reported as follows: skeletal dysplasia group: 18 complication requiring surgery.9 deep surgical site infection.13 hardware failure.6 neuromonitoring change (intraoperative).1 neurological deficit.1 dural tear.Idiopathic group: 20 complication requiring surgery.8 deep surgical site infection.14 hardware failure.1 neurological deficit.1 morbidity.4 anchor failure (skeletal dysplasia group).6 anchor failure (idiopathic group).6 rod fracture (skeletal dysplasia group).4 rod fracture (idiopathic group).This report is for an unknown synthes vertical expandable titanium prosthetic rib (veptr) constructs.It captures the following adverse events in both groups: complication requiring surgery, deep surgical site infection, hardware failure, neurological deficit and dural tear.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11289552
• MDR Text Key: 230955267
• Report Number: 8030965-2021-00869
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

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: 01/27/2021
• Initial Date FDA Received: 02/05/2021
• 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