MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VEPTR IMPLANTS; PROSTHESIS, RIB REPLACEMENT

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown veptr implant/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.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: verhofste b.,et al (2020)spinal deformity in sotos syndrome: first results of growth-friendly spine surgery, j pediatr orthop volume 40, number 9,pages 1-9 (usa)doi: 10.1097/bpo.0000000000001554.This case-series aims to describe the presentation of spinal deformity in patients with ss and eos; and to report the long-term outcomes and complications of gfi in these patients.A total of thirteen patients (9 males, 3 females) with a mean of 3.7 ±2.30 years old (range, 0.4 to 7.5 y) at presentation diagnosed with ss and eos were identified from two multicenter eos databases (1997-2017) and were included in the study.Patients received gfi for the treatment.All procedures were performed through a posterior approach.Eight patients were treated with tgr , 2 received mcgr, and 2 veptr were inserted, and 1 psf.Mean age at index surgery and follow-up duration were 5.0 years (range, 1.8 to 10 y) and 7.2 years (range, 2.1 to 14.9 y), respectively.The following complications were reported as follows: six patients experienced a rod fracture: 3 patients developed 1 rod fracture and 3 patients fractured a rod on 2 separate occasions.A case of a (b)(6) year old male (patient 10) had pneumonia (nonop) and underwent 1 revision.A case of a (b)(6) year old male (patient 11) had rod fracture (unplanned) and underwent revisions 3 times.This report is for an unknown synthes veptr implant.This report captures the reported event of a (b)(6) year old male (patient 11) who had rod fracture (unplanned) and underwent revisions 3 times.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11346146
• MDR Text Key: 232524806
• Report Number: 2939274-2021-00957
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/18/2021
• 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
• Patient Age: 33 MO