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

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k #: this report is for an unknown ala hook/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: parnell, s.E.Et al (2015), vertical expandable prosthetic titanium rib (veptr): a review of indications, normal radiographic appearance and complications, pediatric radiology, vol.45 (4), pages 606-616 (usa).The aim of this study is to reviews the clinical indications and strategies for the use of the veptr device, imaging modalities that may be used in the evaluation and management of patients with thoracic insufficiency syndrome and familiarizes the reader with the types of complications that can occur with emphasis on the radiographic findings that are seen with these complications.An unknown number of patients were included in the study.Surgery was performed using vertical expandable prosthetic titanium rib (veptr; synthes, west chester, pa).The following complications were reported: an (b)(6)-year-old boy had right posterior rib fracture adjacent to the superior cradle of the veptr device.A (b)(6)-year-old girl had migration of the superior rib cradle and erosion through the ribs.An (b)(6)-year-old girl had inferolateral dislodgement of the s-hook and increased thoracolumbar levoscoliosis.An (b)(6)-year-old girl had erosion of hardware (pelvic hook) through the skin with persistent serosanguinous drainage from the wound, raising question of infection.An (b)(6)-year-old girl had abnormal migration of the lumbar hook into the spinal canal at the lumbosacral junction causing soft-tissue damage and radiculopathy.A (b)(6)-year-old boy had migration of the superior cradle over time indicating dislodgement of the cradle from the original rib anchors.A (b)(6)-year-old girl had a fracture (broken hardware) of the inferior portion of the rib sleeve of a hybrid veptr device.This report is for an unknown synthes veptr ala hook.This is report 3 of 7 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: ALA HOOK
• 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: 8889041
• MDR Text Key: 154266292
• Report Number: 2939274-2019-59806
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 07/17/2019
• 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
• Patient Age: 8 YR