MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VEPTR IMPLANTS: SUPERIOR CRADLE; 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 veptr superior cradle/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.(b)(4).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: karlin, l.I.Et al (2021), the growth-friendly surgical treatment of scoliosis in children with osteogenesis imperfecta using distraction-based instrumentation, spine deformity, vol.9 (xx), pages 263¿274 (usa).The aim of this two multi-center database-specific retrospective case study is to determine the feasibility of growth-friendly distraction-based surgery in children with oi.A total of 5 patients were included in the study.Surgery was performed using veptr in one patient (patient #3) and a competitor device in 4 patients.All patients had a minimum of 2-year follow-up.The mean follow-up period was unknown.The following complications were reported as follows: patient #3 - a (b)(6) male patient, had a veptr construct: a unilateral rib-rib and rib-spine construct.This construct was converted to a bilateral pelvis to rib construct after 4 years of treatment.The patient underwent a total of 11 surgeries: 1 initial procedure, 9 lengthenings, and 2 unplanned surgeries.There were 6 instrumentation failures and revisions: (1, 2) 2 cephalad cradle replacements, (3) l3 supralaminar hook-replaced with l5 pedicle screw, (4) infected, loose l5 pedicle screw replaced by l5 supralaminar hook, (5) l5 hook replaced by pelvic hook, (6) placement of right-sided pelvis to rib veptr to improve correction.Revisions #4 and #5 were unplanned surgeries.This report is for an unknown synthes veptr superior cradle.It captures the reported case of a (b)(6) male patient who had instrumentation failure: 2 cephalad cradle replacements.This is report 3 of 6 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: SUPERIOR CRADLE
• 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: 11354787
• MDR Text Key: 232884078
• Report Number: 2939274-2021-00984
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 02/01/2021
• 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: 6 YR