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

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unk - constructs: veptr/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.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: iyer, r.Et al (2022), a103: salvage treatment of failed growth-friendly surgery for early onset spinal deformity, global spine journal, vol.12 (3s), page 60s (usa).The aim of this retrospective case series is to describe the authors' institutional experience with salvage therapy for failed growth friendly surgery (f-gfs) in early onset spinal deformity (eosd) patients, seeking to increase the awareness of this patient population by describing the clinical management and treatment outcomes.A total of 29 patients with early onset spinal deformity patients who had failed growth friendly surgery and subsequent salvage treatment at a tertiary children¿s hospital were reviewed.Mean age at first surgery was 5.3 ± 2.6 years.In most cases, index surgeries were performed at outside institutions, while the most recent surgical treatment was performed by the senior author in the majority of cases.Patients were previously instrumented with veptr (7), tgrs (10), mcgrs (4), shilla (3), or none/in-situ fusions (6).The following complications were reported as follows: 7 patients who were previously instrumented with veptr had a failed growth friendly surgery and underwent subsequent salvage treatment.The article does not provide sufficient information to identify which device manufacturer is associated with the adverse event as follows: indications for intervention included curve progression and one or more of the following findings: 1.Trunk imbalance, 2.Neurological compromise, 3.Respiratory insufficiency, and 4.Wound issues and/or implant prominence.Among the 29 patients, 16 patients (55.2%) presented with scoliosis > 90 degrees, and 19 (65.5%) presented with kyphosis > 90 degrees.14 patients (48.2%) had both kyphosis and scoliosis > 90 degrees.Nine patients (31%) presented with evidence of a neurological deficit, including weakness and/or myelopathy.For salvage of these 29 patients, 16 (55%) underwent preoperative halo-gravity traction (hgt) for an average of 4.9 ± 2.5 weeks.21 (72%) underwent staged procedures and 21 (72%) underwent vcr.6 (21%) had placement of a new growing system.This report is for an unknown synthes veptr.This is report 1 of 1 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15362068
• MDR Text Key: 299300470
• Report Number: 8030965-2022-06407
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 08/10/2022
• 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