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

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown veptr implants/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: anari, j.B.Et al (2020), unplanned return to or (upror) for children with early onset scoliosis (eos): a comprehensive evaluation of all diagnoses and instrumentation strategies, spine deformity, vol.8 (xx), pages 295¿302 (usa).The aim of this retrospective analysis of a prospectively collected multicenter database is to study unplanned return to the or (upror, a postoperative complication that could not be treated without an additional anesthetic) as a function of c-eos diagnosis and implant type.Between october 4, 2010 to september 27, 2015, a total of 369 patients were included in the study.Surgery was performed using vertical expandable prosthetic titanium rib (veptr) in 260 patients, and competitor devices for the rest of the patients.The average follow-up for the veptr group was 4.8 years.The following complications were reported as follows: 55 patients with veptr required unplanned trips to the operating room for various reasons.The reasons for the unplanned reoperation were anchor failure (n=123), irrigation and debridement (n=44), removal (n=14), exchange (n=9), conversion operation (transitioning from a veptr to a mcgr; n=7), additional implant placement (n=6), initial implant (n=5), other (n=1).92 patients with veptr had unplanned reoperation at 2 years.1 patient had infection.7 patients had proximal anchor failure.7 patients had distal anchor failure.This report is for an unknown synthes veptr implants.It captures the reported evens of anchor failure.This is report 2 of 2 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: 11382236
• MDR Text Key: 233744168
• Report Number: 2939274-2021-01060
• 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: 02/03/2021

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: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• 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