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

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes vertical expandable prosthetic titanium ribs (veptr) implants: 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: campbell r., smith m., (2007), thoracic insufficiency syndrome and exotic scoliosis, the journal of bone & joint surgery, february 2007, volume 89(1), pages 108-122, (usa).This study aims to define exotic scoliosis as an early-onset spinal deformity that is more complex in nature, often associated with a thorax that has been distorted by spinal lordosis and curve rotation, thus having a volume-depletion deformity as well as thoracic growth inhibition with indirect adverse effects on lung growth and evaluate possible treatment option whether it includes observation, bracing or casting, growing spinal rods, spine fusion, or vertical expandable prosthetic titanium ribs (veptr) expansion thoracoplasty, effect on the present level of thoracic insufficiency syndrome and the long-term effect of a specific treatment on the level of this disorder.Between 1989 to 2004, a total of 201 patient with thoracic insufficiency syndrome were included in the study.The veptr device (synthes spine, west chester, pennsylvania) was available for use.Specific veptr surgical strategies are based on the respective volume-depletion deformities to be corrected by various types of veptr expansion thoracoplasty.For type-i volume-depletion deformity: absent ribs and scoliosis two to three veptr devices (radius,220 mm) are usually used.For type type-ii volume-depletion deformity: fused ribs and scoliosis, in children up to age eighteen months, a single rib-to-rib 220-mm-radius veptr is implanted.For type-iia volume deformity: jarcho-levin syndrome a staged bilateral opening-wedge thoracostomies22 are performed for this volume-depletion deformity with the placement of rib-to-rib (radius, 220 mm) veptr devices.For type-iiib volume-depletion deformity: jeune syndrome or infantile scoliosis with windswept deformity staged bilateral dynamic segmental expansion thoracoplasties, stabilized with an acutely curved veptr (radius, 70 mm), are performed to address the circumferential thoracic constriction.The mean duration of follow-up is 6 years.The following complications were reported as follows: infection rate per procedure was 3.3%.Skin slough was seen in 8.5% of the patients.No improvement in the thoracic rotation is seen postoperatively with correction of the kyphosis (figure 9-b).Device breakage in patients is 6%.Posteroinferior migration of the spinal hybrid hook into the posterior spinal elements.Migration of the superior rib cradle into the rib of attachment.This report captures the adverse event of migration of the superior rib cradle into the rib of attachment.This report is for an unknown synthes vertical expandable prosthetic titanium ribs (veptr) implants: superior cradle.This is report 2 of 2 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: 8742002
• MDR Text Key: 149481440
• Report Number: 2939274-2019-58903
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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: 06/03/2019
• 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