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

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr implants/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.(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: takata y., lenke l., kelly m., (2020) posterior vertebral column resection for rigid proximal thoracic kyphoscoliosis with broken growing rods in a patient with desbuquois dysplasia,spine deformity volume 8, pages 135¿138(usa).This study presents a case report of a patients to describe a patient with desbuquois dysplasia associated with severe cervicothoracic kyphoscoliosis with a failed growing rod construct, who was successfully treated with preoperative halo-gravity traction and a posterior vertebral column resection (pvcr).A case of an (b)(6)-year-old girl with a history of desbuquois dysplasia and tracheomalacia had been referred, having undergone multiple surgeries (single veptr [vertical expandable prosthetic titanium rib] rod, double veptr rods, anterior release through a thoracotomy, and serial growing rod lengthenings), for treatment of progressive angular thoracic kyphoscoliosis.Her rods had broken a few months before presentation and she developed a progressive proximal thoracic deformity which diminished her appetite, resulting in a several-pound weight loss.Physical examination showed a small and cachectic (35 in, (b)(6) lb) girl with multiple healed surgical wounds, a prominent protrusion on her back over the broken rods, as well as a chin-on chest deformity.She had no neurologic complaints.Upright radiographs showed cervicothoracic kyphosis of + 144° and compensatory lumbar lordosis of - 58°.She underwent removal of the broken implants and was placed in halogravity traction to partially correct the severe kyphosis and lift her chin off her chest.Traction was gradually applied.Her kyphosis was corrected to 113°.Spirometry was performed, which showed a forced vital capacity of 0.61 and forced expiratory volume in 1 s of 0.59 (91.7% and 80.7% of predicted, respectively).She then underwent posterior reconstruction surgery.Iatrogenic solid fusion from c7 to t4 and from l1 to l4 was confirmed.Her surgical procedure included posterior column osteotomies from t5-6 to t9-10, laminectomies from inferior t3 to t5, t4 pvcr, and an instrumented fusion from c7 to l4.There were no neurologic complications.At the 2-month postoperative visit, she was 39 in tall and (b)(6) lb in weight, having gained 4 in in height and (b)(6) lb of weight since we first saw her.At the 2-year follow-up visit, the correction was well maintained and there was no implant failure.She stands with a normal weight bearing line.This report is for an unknown synthes single veptr [vertical expandable prosthetic titanium rib] rod and double veptr rods.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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11348390
• MDR Text Key: 232852777
• Report Number: 2939274-2021-00964
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• 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: 8 YR
• Patient Weight: 15